Qc Associate Resume Samples

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JV
J Vandervort
Johnnie
Vandervort
9662 Parisian Fall
Dallas
TX
+1 (555) 598 7903
9662 Parisian Fall
Dallas
TX
Phone
p +1 (555) 598 7903
Experience Experience
New York, NY
Qc Associate
New York, NY
Considine-Stokes
New York, NY
Qc Associate
  • Perform rework of product as necessary
  • Participate in and/or lead group and project teamwork; project and process improvements
  • Perform other duties as requested by managers to support Quality activities
  • Perform adhoc duties, as requested by the Quality Team Leader or Quality Manager, to support activities of the Quality department
  • Assist in cleanliness of general work area
  • Create and manage excel tracker for better monitoring of QC initiatives
  • Communicate effectively with other co-workers, departments, management and clients
Phoenix, AZ
Senior Qc Associate
Phoenix, AZ
Hudson-Dach
Phoenix, AZ
Senior Qc Associate
  • Provide input to the development of personal performance goals and departmental objectives
  • Collaborate with Management to establish and meet targets and timelines
  • Support new product development and continuous improvement by integrating QC tools and techniques
  • Perform any other tasks as requested by Management to support Quality oversight activities
  • Develop QC Department SOPs and Work Instructions
  • Write protocols and perform assay validation and equipment qualification/ verification
  • Any other tasks/projects assigned as per manager's request
present
Chicago, IL
Qc Associate Senior
Chicago, IL
Dickinson-Murazik
present
Chicago, IL
Qc Associate Senior
present
  • Perform general housekeeping in all sample management areas
  • Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis
  • Perform routine sample management procedures
  • Manage all sample management activities throughout the site
  • Out of hours responder for sample management equipment (fridges /freezers / incubators)
  • Responsible for SAP and LIMS functions/ transactions within the sample management remit
  • Create/own and approve protocols, sample plans, SOP and documentation
Education Education
Bachelor’s Degree in Technical Flexibility
Bachelor’s Degree in Technical Flexibility
Indiana University
Bachelor’s Degree in Technical Flexibility
Skills Skills
  • Flexible: able to respond quickly to shifting priorities and meet deadlines
  • Knowledgeable and conversant with 21CFR, USP, EP, and ICH regulatory guidelines
  • Demonstrated ability to perform most tasks with limited supervision:general instructions on routine work, detailed instructions on new assignments
  • Self-starter, organized, attention to detail and accuracy, the ability to work independently and in a team environment, are essential
  • Ability to communicate effectively and follow detailed written and verbal instruction
  • Ability to perform a variety of simple laboratory tasks
  • Experience working in a GMP (GxP) environment (desirable)
  • Able to work under pressure and to support others within the team
  • Basic Genetics
  • Basic statistical analysis techniques
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15 Qc Associate resume templates

1

Qc Associate Senior Resume Examples & Samples

  • Manage all sample management activities throughout the site
  • Create/own and approve protocols, sample plans, SOP and documentation
  • Site ownership of stability programme
  • Responsible for SAP and LIMS functions/ transactions within the sample management remit
  • Site ownership of Reference standards and reserves
  • Out of hours responder for sample management equipment (fridges /freezers / incubators)
  • Responsible for their own training and safety compliance
  • Sample shippments and temperature monitoring activities
  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Bachelor's degree in a Science related field is required
  • 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
2

Senior Qc Associate Resume Examples & Samples

  • Authoring, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment
  • Writing equipment validation protocols and associated summary reports
  • Maintaining a current working knowledge with regards to regulatory requirements for equipment qualification and calibration
  • Generation and resolution of protocol discrepancies as required
  • Alerting Quality Control Management in the event that equipment fails to meet calibration or qualification requirements, and conducting impact assessments/investigations as required
  • Participation in technical project teams in order to act as a subject matter expert on instrument validation regulations and procedures
  • Serving as the point of contact with laboratory equipment vendors and engineers
  • Writing/contributing to equipment operating procedures and manuals
  • Adhere to Change Control metrics
  • Conduct periodic reviews of instrument validation as part of validation life cycle
  • Conducting review of calibration and maintenance documentation related to laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo
  • Filing of QC qualification, calibration & maintenance documentation
  • Any other tasks/projects assigned as per manager's request
  • Minimum of 3 years' experience in a cGMP environment, experience of executing analytical instrument validation would be a distinct advantage
  • Good understanding of Windows® Operating Systems and proven experience of troubleshooting issues identified during laboratory systems validation
  • Experience of authoring cGMP Validation documents in a controlled document system
  • Experience of executing cGMP Validation documents in a controlled document system
  • Experience of resolving Protocol Deviations
  • Awareness of Change Control philosophy in the cGMP environment
  • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record / electronic signature integrity assessments
  • Knowledge of the methodology and instrumentation used for biopharmaceutical testing
  • Ability to work on own initiative within a cross functional team environment
3

Senior Qc Associate Resume Examples & Samples

  • Bachelor's degree in a science discipline
  • Biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Minimum 5 years' experience required
4

Senior Qc Associate Resume Examples & Samples

  • Plan and perform routine analyses with efficiency and accuracy
  • Initiate and/or implement changes in controlled documents
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope
  • Write protocols and perform assay validation and equipment qualification/ verification
  • May participate in lab investigations
  • May provide technical guidance
  • May train others
  • May contribute to regulatory filings
  • May represent the department/organization on various teams
  • May interact with outside resources
5

Qc Associate Resume Examples & Samples

  • With a high degree of technical flexibility, work across diverse areas within the lab
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
  • Report, evaluate, back-up/archive, trend and approve analytical data
  • Troubleshoot, solve problems and communicate with stakeholders
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis
  • Approve lab results
  • Participate in lab investigations
  • Provide technical guidance
  • May be needed to train others
  • Contribute to regulatory filings
  • Represent the department/organization on various teams
  • Interact with outside resources
6

Qc Associate Resume Examples & Samples

  • Conducts routine analysis and testing of samples under general supervision and may focus analysis and testing in a particular QC arena
  • Performs assays. Releases testing assays for in process, final product, raw materials and other routine samples
  • Compiles data for documentation of test procedures
  • Reviews data obtained for compliance specifications and reports abnormalities
  • Collects and disposes of lab wastes according to established procedures
  • Assists in the transfer, qualification and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports
  • Trains lower level personnel on quality control methods and SOP’s
7

Qc Associate Resume Examples & Samples

  • Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential
  • Flexible: able to respond quickly to shifting priorities and meet deadlines
  • Basic molecular biology laboratory skills such as pipetting, PCR, gel electrophoresis, etc. required
  • Experience with DNA or RNA sample preparation, sequencing, qPCR, robotics and/or Illumina technology is a plus
  • Experience and familiarity with instrumentation a plus
  • PCR
  • Gel extraction
  • CDNA synthesis
  • Basic Genetics
  • Basic statistical analysis techniques
  • Microarray assays and technology
  • Experience with large data sets a plus
  • Experience with robotics a plus
  • Experience with Illumina products also a plus
  • BS/MS in Biology/Molecular Biology biochemistry, chemistry or related discipline
  • Two to Five years of industry experience with Functional analysis QC of molecular-biology-based assays required,
  • Ability to understand and follow work instructions and perform molecular biology assays with little guidance
  • Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
  • GMP experience a plus
8

Qc Associate Resume Examples & Samples

  •  Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods
  •  Analysis of data generated by functional assays
  •  Participate in developing and validating testing methodology, revising and updating Standard Operating Procedures
  •  Review data obtained for compliance to specifications and report abnormalities
  •  Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential
  •  Flexible: able to respond quickly to shifting priorities and meet deadlines
  •  Basic molecular biology laboratory skills such as pipetting, PCR, gel electrophoresis, etc. required. Experience with DNA or RNA sample preparation, sequencing, qPCR, robotics and/or Illumina technology is a plus
  •  Experience and familiarity with instrumentation a plus
  •  PCR
  •  Gel extraction
  •  cDNA synthesis
  •  Basic Genetics
  •  Basic statistical analysis techniques
  •  Microarray assays and technology
  •  Experience with large data sets a plus
  •  Experience with robotics a plus
  •  Experience with Illumina products also a plus
  •  Ability to understand and follow work instructions and perform molecular biology assays with little guidance
  •  Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
  •  GMP experience a plus
9

Temp QC Associate Resume Examples & Samples

  • Review notebook documentation, raw data and other documentation at an extremely detailed level for accuracy, consistency and completeness
  • Ensures sample data are documented in a manner that is compliant with GLPs, protocols and SOPs
  • Reviews all data (notebook documentation, raw data, and LIMS data), study reports, assay validation reports and other documentation in a timely manner to meet project timelines
  • Identify and communicate findings in a clear and concise manner and verify appropriate corrections have been made
  • Follow GLPs and internal procedures (SOPS, working practices)
10

QC Associate, Contractor Resume Examples & Samples

  • Understanding statistical data-listings, tables and figures to ensure they are incorporated and interpreted appropriately into the written document
  • Verifying source data to written document in clinical study reports and regulatory submission documents
  • Assisting in the resolution of comments from Quality Assurance
  • Cross functional interactions include medical writing, QA, regulatory, Pharmacovigilance, statistics and clinical teams
  • The applicant would have previous experience in reviewing statistically generated Tables, Listings and Figures, reviewed clinical study reports and submission documents
  • Applicant must be able to communicate well with cross functional areas such as medical writing, regulatory, data management and statistics
  • This individual will also support the clinical operations functions in responding to Quality Control Audits, Regulatory Inspections
  • The applicant must be able to communicate with other functional groups on the documents needed, such as source documents, in order to perform a 100% QC
11

Qc Associate Resume Examples & Samples

  • Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods
  • Analysis of data generated by functional assays
  • Participate in developing and validating testing methodology, revising and updating Standard Operating Procedures
  • Review data obtained for compliance to specifications and report abnormalities
  • Basic molecular biology laboratory skills such as pipetting, PCR, gel electrophoresis, etc. required. Experience with DNA or RNA sample preparation, sequencing, qPCR, robotics and/or Illumina technology is a plus
  • Analytical Equipment Experience (HPLC, ICS, Mass Spec) is a plus
12

Qc Associate Resume Examples & Samples

  • B.S/B.A. in Microbiology, Biology, Biotechnology, or related field with no previous industry laboratory experience
  • Associates Degree/Certificate/Diploma in laboratory science with minimum of 2 years experience in a laboratory
  • Preferred - Mammalian cell culture experience
  • Good documentation practices, cGMP preferred
  • Ability to communicate effectively and follow detailed written and verbal instruction
  • Ability to cooperate with coworkers within an organized team environment or work alone with supervision
13

Qc Associate Resume Examples & Samples

  • Document and review executed procedures and record data in compliance to Quality System specifications
  • Support Return material authorization (RMA) activities
  • Documentation review and release of incoming raw materials and final products release in compliance to internal specifications
  • Perform general lab maintenance (i.e. ordering of lab consumables)
  • Tests and inspects incoming materials using standard operating procedures
  • Perform routine and non-routine analytical, molecular and biochemical assays according to business needs
  • Maintenance / calibration / inspection of measuring devices, equipment and procedures for accuracy
  • Report abnormalities and support troubleshooting / investigation of laboratory equipment/test/nonconforming material
  • Other such duties that may be determined by Management
14

Temporary QC Associate Level Resume Examples & Samples

  • Analysis of environmental samples according to Standard Operating Procedures and Test Methods
  • Routine environmental monitoring of air, surface, water, gas and steam systems
  • Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
  • General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
  • Complete GMP and Safety Training
  • Problem solving of test methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next
  • Perform general lab support
  • Perform assay review when achieve assay competency with supervisor direction
  • Initiation, review and closure of Deviations
  • Perform document changes
  • Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs
  • All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc)
  • All personnel should practice good sanitation and health habits
  • Personnel suffering from an infections disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs
  • Environmental Monitoring/Microbiology Lab experience in biotech or medically related field
15

Temporary QC Associate Level Resume Examples & Samples

  • Unning test samples for In-Process, Lot Release and Stability studies
  • Reviewing assays
  • Training others
  • Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
  • Strong communication, interpersonal and organizational skills
16

Qc Associate Resume Examples & Samples

  • Coordinate the sampling of all incoming starting materials
  • A minimum of 1 year experience in a pharmaceutical or other regulated industry preferred
  • Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts
  • Ability to handle multiple projects with competing priorities
  • Basic fundamental understanding of mathematics. Intermediate skills in computer use with ability to learn and master new computer applications
  • Self-directed and motivated, detail oriented, quality minded with strong organizational skills
  • When required, interact with internal and external auditors
  • Understands paperwork review process
  • Ability to follow written procedures and exhibit excellent documentation practices
  • Ability to take on additional tasks, as required
17

Qc Associate Resume Examples & Samples

  • Follow established protocols and SOP’s to test raw material and components for QC acceptability
  • Perform daily assignments following written procedures and SOP’s
  • Ability to troubleshoot instrument problems when necessary
  • Conducting visual and measurement tests; rejecting and returning unacceptable materials
  • Approves in-process production by confirming specifications; communication required adjustments to supervisor and generating NCR’s and Change Orders when necessary
  • Handles incoming inspection in a timely manner which includes but not limited to sample analysis, batch record review, historical trend reviews, and official documentation findings
  • Careful documentation of lab procedures
  • Ability to follow written procedures
  • Flexibility with schedule may be required
  • Preparation, daily maintenance, and use of next-generation sequencing instruments and equipment
18

Qc Associate Resume Examples & Samples

  • Quality Control Testing of Instruments with focus on Octet and BLItz
  • Quality Control Testing of Consumables for Octet and MicroReactor as needed
  • Cross train on QC procedures for new PALL products manufactured in Menlo Park
  • Maintain inventory of materials needed for QC Testing
  • Perform data analysis to report test results
  • Prepare documentation required for product release to Finished Goods Inventory
  • Prepare data summaries and clearly communicate test results in different forums
  • Maintenance of existing Quality Control protocols and documentation
  • Maintain databases for performance tracking
  • Generate and update SOPs and Documentation for testing procedures
  • Participate in other QC activities as needed
19

Qc Associate Resume Examples & Samples

  • Perform a broad variety of basic and moderately complex tests with documentation according to GMP
  • Review data and assess against established acceptance criteria
  • Perform technical review of peer-generated data
  • Evaluate data to identify trends and/or establish limits
  • Identify discrepancies. Provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
  • Identify and troubleshoot technical problems
  • Identify gaps in systems and procedures
  • Receive and provide training
  • Participate in assay transfer and assay validation
  • Perform equipment qualification / maintenance
  • Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
  • Support the maintenance and compliance of operational areas
  • Assure and apply GMP throughout operations
  • Coordinate with customers to support multi-site operational activities
  • Support internal and external audits and regulatory inspections
  • Works to meet schedules, timelines, deadlines
  • Participate in and/or lead group and project teamwork; project and process improvements
  • Meets scheduled performance of 95% on time
  • Perform other duties as requested by managers to support Quality activities
20

Qc Associate Resume Examples & Samples

  • Perform testing of routine and non-routine samples and document according to GMP
  • Perform technical review of peer-generated data for basic methods
  • Prepare data tables and graphs
  • Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
  • Prepare and maintain standards, controls, stocks, and cultures per established procedures
  • Coordinate with customers to support operational activities
  • Work to meet schedules
  • Identify and support resolution of technical problems
  • Actively participate in group projects such as process improvements
  • Drafts protocols and reports under supervision
  • Support the preparation of the schedule or other planning activities
21

Senior Qc Associate Resume Examples & Samples

  • Conduct analytical testing on products and APIs following established SOPs and GMP requirements using HPLC and other analytical instruments
  • Review and approve analytical test results for product release and Stability studies
  • Troubleshoot and investigate any routine and non-routine technical problems
  • Participate in method validation, transfer process, and equipment validation
  • Prioritize, schedule, and allocate resources appropriately to ensure efficient workflow, meet production schedules, and full synchronization with our Process Unit (PU) group
  • Provide training and mentoring to other associates on analytical methods, lab instrumentation operation and troubleshooting, etc
  • Act as a lead investigator on laboratory deviations and outside-of-specification results
  • Lead and drive QC process improvement projects
  • Generate, maintain, and revise test monographs, SOPs, analytical methods and specifications to ensure compliance with regulatory requirements and filings
  • Perform QC analytical data trending and analysis using Minitab or similar tools to calculate continuous process verification (CPV) limits
  • Author stability reports and other technical writing requests
  • Ensure compliance with GMP/HSE regulations, Novartis policies, procedures and standards appropriate for this role
  • Champion a Quality Culture and help ensure a safe working environment
22

QC Associate, Analytical Resume Examples & Samples

  • Performs routine HPLC and MS analysis and testing according to Standard Operating Procedures with GMP documentation (in-process, release, and stability)
  • Analyzes data and processes data using Chromeleon and MassHunter
  • Prepares mobile phases, solutions, and buffers according to standard operating procedures to support HPLC operations
  • Manages laboratory inventory of raw materials and supplies
  • Maintains instrumentation according to standard operating procedures
  • Maintains lab area including cleaning of benches, biosafety cabinets and shelving
  • Initiates revisions to current SOPs and authors new SOPs based on methodology being transferred
  • Ensure analytical methods are properly validated/qualified as appropriate in compliance with GMP
23

Senior Qc Associate Resume Examples & Samples

  • Ensuring the quality of incoming raw materials, in-process, stability and release testing of samples following SOPs, Work Instruction (WI) and GMP guidelines
  • Document all analysis following approved work instructions and GMP guidelines
  • Assist with the maintenance of QA monitoring programs, such as internal audits
  • Support new product development and continuous improvement by integrating QC tools and techniques
  • Create and maintain required QC process documentation. Generate certificate of analysis
  • Participate in lab investigations; respond to corrective and preventive actions related to laboratory investigations
  • Support manufacturing and other lab operations
  • Troubleshooting of equipment issues
  • Other duties, which may be assigned, based on the need
  • B.S. science related degree (such as Biochemistry, Molecular Biology, Biotechnology etc.) with 3-5 yrs. in an industry setting (in-vitro diagnostic environment a plus)
  • Understanding of molecular biology, assay development, and DNA diagnostic chemistry is highly desirable
  • Success working in a team-based cross functional organization,
  • Be highly self-motivated, an excellent communicator, highly analytical,
  • Have the ability to work in a fast-paced environment and maintain focus on deliverables
  • Experience in laboratory techniques such as RT-PCR and UV/VIS is highly desirable
  • Ability to understand and utilize custom instrumentation
  • Understanding and awareness of cleanliness, such as sterile technique, in a PCR laboratory is required
  • High attention to detail adhering to regulatory guidelines
24

Qc Associate Resume Examples & Samples

  • MS/BS/BA in relevant field and 0-2 years of relevant experience; or
  • HS/GED/Associates and 2-5 years of relevant experience
  • Prior experience in a regulated environment
  • Expert knowledge of GxPs and industry guidance documents
25

Qc Associate Resume Examples & Samples

  • Be monitoring drivers and passengers' behaviour
  • Prepare daily reports coming from GAMMA and Holistics
  • Monitor Driver and Passenger complaints
  • Be creating modules for Training and Coaching
  • Initiate Meeting/Training/Coaching of drivers and peers
  • Be managing of accident reports involving Grab drivers
  • Call and SMS re:driver communication in connection with suspension and complaint investigation
  • Create and Revised guidelines and processes in connection with Quality Assurance
  • Create and manage excel tracker for better monitoring of QC initiatives
  • Do decision making in connection with driver and passenger cases
  • Must be a college graduate preferably IT, Psychology or Education
  • Must have at least one (1) year working experience
  • Preferably with experience in the same field, quality assurance or quality control
  • Must be excellent in using MS Word, Excel and Powerpoint
  • With good People skills/Training/Willful/Data oriented
  • Must have a strong decision making skill
  • Can deal with different personalities
  • Can competently work under pressure
26

QC Associate, Chemistry Resume Examples & Samples

  • Executes transfers, qualifications and validations of new testing methods with guidance from supervisor, which may include authoring protocols and reports
  • Manages IQ/OQ/PQ of new instruments with guidance from supervisor
  • Performs wet chemistry compendial assays. Releases testing assays for in process, final product, raw materials and other routine samples
  • Adheres to cGMP requirements and SOP’s
  • Responsible for standardization and maintenance of laboratory equipment
  • Reviews batch records and product specifications as required
  • Maintains lab area including routine cleaning of benches, biosafety cabinets, shelving and floors
  • Trains junior team members on quality control methods and SOP’s
  • Participates in Client Interface meetings as may be required or necessary
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
27

Qc Associate Resume Examples & Samples

  • ≥70% time spent in laboratory
  • Performs advanced assays for gene therapy products
  • Secondary review of data
  • Evaluates data and trends results
  • Conducts laboratory investigations/UERs
  • Acts as Product/Project Coordinator
  • Responsible for completion and compilation of data for product/project
  • Interacts with other departments at BioMarin on a regular basis
  • Provides technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for clinical products
  • Writes technical reports
  • Mentors new hires
  • Directly supervises no more than 1 hire
  • Provides support to other analysts
  • Maintains laboratory in inspection ready state and is expected to participate during internal and external inspections/audits
  • Perform molecular biological, biochemical/chemical analyses of drug substance, drug product, clinical and stability samples under cGMP to meet specified timelines
  • Provide technical expertise and leadership to QC Analysts
  • Evaluate data and trend results
  • Troubleshoot assays
  • Prepare protocols, summaries and reports for routine and non-routine studies and analytical method validations
  • Maintain the laboratory in an inspection ready state
  • Interface with contract facilities and other BioMarin departments as necessary
  • At least five years in a cGMP laboratory; quality control experience required
  • Well-developed laboratory skills for analysis of pharmaceuticals, biopharmaceuticals
  • Demonstrated ability to perform most tasks with limited supervision:general instructions on routine work, detailed instructions on new assignments
  • Knowledgeable and conversant with 21CFR, USP, EP, and ICH regulatory guidelines
  • Well-developed laboratory skills for analysis of pharmaceuticals, biopharmaceuticals. (experience in mammalian and insect cell culture, cell based assays, qPCR, HPLC, ELISA, SDS-PAGE)
28

Qc Associate Resume Examples & Samples

  • Plan, organize and manage daily activities for the stability program, including study set up and sample management
  • Generate, review and trend stability data tested internally and at CMO’s
  • Prepare stability sections for regulatory submissions (BLA, IND, etc.)
  • Performs regular maintenance of QC equipment
  • Author stability protocols and reports
  • Provide technical support during release testing at contract manufacturing/testing (CMO) organizations
  • Prepare Certificates of Analysis (CoA) for CMO products and materials
  • Authors, revises, and reviews Dendreon and CMO SOP’s, product specifications, and investigations
  • Participate on project teams representing the Quality Control (QC) department
  • Work closely with internal departments, including Quality Assurance, Contract Manufacturing, Development, and Process Engineering
  • Adheres to good documentation practices to ensure data integrity and traceability
  • Intermediate level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys)
  • Knowledge of cGMP/QSR/ICH, FDA stability guidelines and FDA device/drug/biologics regulations preferred
  • Strong knowledge of and/or hands-on experience with the following methodologies: HPLC, UV Spectrophotometry, bioassays, ELISA, SDS-PAGE, and peptide mapping, cell culture
  • Ability to prioritize and successfully manage complex and competing projects
  • Attention to detail, quality and compliance
  • Proficient in MS Office applications
29

Senior Qc Associate Resume Examples & Samples

  • Ensure the supply and quality of consumables and reagents
  • Perform QC of consumables to defined procedures
  • Complete QC batch records using Good Documentation Practices
  • Maintain laboratory to clean room standards required in the production of Life Science products
  • Operate to industry standard protocols to ensure the integrity of the product being manufactured
  • Accurate tracking of test data and inventory
  • Disposition material based on QC data and production data
  • Perform data trending to determine potential issues and root causes of failing batches
  • Experience in performing standard molecular biology analytical techniques such as PCR/qPCR/ddPCR, PAGE analysis, HPLC, flow cytometry, DNA quantitation, DNA Sequencing
  • Accurate and consistent laboratory skills to ensure the quality of the product
  • Assist in the development of processes and products. This includes performing product and process optimization, guard band studies, stability studies, gauge R&R
  • Assist in validating new equipment by drafting and executing IQ/OQ/PQ plans
  • Draft non-conformance and deviation reports
  • Develop QC Department SOPs and Work Instructions
  • Train junior QC Associate on lab techniques and Manufacturing workflows
  • Lead and assist in troubleshooting non-conforming lots to determine root causes
  • Participate in setting and reviewing specifications for new QC assays
  • B.S. in one of the following disciplines: Molecular Biology, Analytical Chemistry or Chemical Engineering
  • 5 years relevant laboratory experience in manufacturing and QC testing of life science products, such a DNA sequencing, PCR or other nucleic acid based technologies
  • Ability to troubleshoot with minimal supervision
  • Able to multi-task and meet strict deadlines to ensure on time customer delivery
  • Experience in Lean Six Sigma techniques and statistical analysis is desirable
  • Ability to articulate and present data to audiences with various backgrounds
  • Experience in ISO 9001/13485 certification and participation in ISO audits
  • Relevant experience in a production environment working with standard production control tools – ERP, SPC, LIMS, inventory control, work orders
  • Ability to write/review standard operating procedures, work instructions and reports
  • Desire to be part of a rapidly evolving organization and taking products and processes to the next level
30

Senior / QC Associate Resume Examples & Samples

  • NITEC, Diploma or Degree in Chemistry, preferably with 1 year of laboratory experience in a related area
  • For a senior position, NITEC, Diploma or Degree in Chemistry (or equivalent), preferably with more than 5 years of related laboratory experience
  • Performs equipment calibration, maintenance and validation as assigned
  • Performs peer review for verification of task and data
  • Assists in SOPs writing
  • Participates in method verification and method validation/transfer (when required)
  • Identify and report problems in QC to supervisor in timely manner
  • Practises 6S and ensures good housekeeping of laboratory, work area and equipments
  • Ensures good inventory of QC materials (purchased and prepared materials/glassware) to support testings; ensures no over-surplus of inventory
  • Ensures wastes are disposed appropriately and promptly
  • Assist the senior supervisor/supervisor in the management and operations of the team; may be indirectly responsible for a team of analyst
  • Scheduling and assures timely availability of test results
  • Reviews test reports and to ensure accuracy of test results in accordance with corporate, regulatory and external agency regulations
  • Provide training to the team
  • Provide guidance, support and technical expertise to the team
  • Involves in investigation and protocol writing (when required)
  • Involve in SOP writing and updating
  • Organisation and Problem Solving
  • Create strong team morale and a culture of accountability
  • Recommend and coordinate appropriate corrective actions to quality problems in conjunction with other teams/departments
  • Present in a timely manner major issues to the management with strategies on their resolution
31

Qc Associate Resume Examples & Samples

  • Performing the following QC Checks
  • Receiving – to include but not limited to; Review and approval where applicable of received goods and Rejecting incorrect goods and notifying appropriate personnel
  • Packaging and Labeling – to include, but not limited to; Line Clearance checks, Start up, middle and End Checks during production and Provide assistance where required in the event of a production error
  • Dispatch of Material/Equipment/Kits – to include, but not limited to; Final inspection of packed orders prior to collection, Release of packed orders for collection and Rejecting incorrect orders and notifying appropriate personnel
  • Kitting – to include, but not limited to; Line Clearance checks, Start up, middle and End Checks during production and Provide assistance where required in the event of a kit production error
  • Label Control – to include, but not limited to; Inspection of internally and externally printed labels against label specifications, Inspection of associated label log books and Rejection and destruction of incorrect labels
  • Laboratory Processing; Performing inspections as required
  • Updating inventory systems for QC release
  • Identify, escalate and support investigations for any identified internal and/or external non-conformances, identified during QC checks, or notified to QC by another function
  • Recording QC Metrics as required
  • Performing documentation review of general processing documents such as, but not limited to; Receipt Records, Dispatch Records, Calibration Records, Line Clearance Records, Kit Production Records and Laboratory Processing Records
  • To ensure during review documentation is correct, GMP compliant, error-free, and entered into operating systems appropriately
  • Perform adhoc duties, as requested by the Quality Team Leader or Quality Manager, to support activities of the Quality department
  • Educated to A-Level or equivalent, in relevant subjects
  • A high degree of accuracy and attention to detail
  • Ability to read and interpret general procedures and governmental regulations
  • Ability to effectively present information and respond to questions from groups of managers, clients and inspectors
  • Ability to calculate figures and amounts such as proportions, percentages, area, and volume
  • Proficient in personal computer skills; specifically Microsoft Office, Outlook and database management
  • Good verbal and written communications
  • Ability to demonstrate experience of working without direct supervision/under own initiative within the remit of the role
  • Builds good working relationship with others
  • Able to work under pressure and to support others within the team
  • Employment is subject to 10 year screening for criminal records, qualifications, previous employment and credit history – Thermo Fisher Scientific have the right not to employ people failing to meet the standards required
  • This position functions in a repository environment, which may include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, as well as marked changes in temperature
  • May be required to perform off site work where necessary
  • Travel as required
  • Valid driver’s license and a good driving record (preferable)
  • Experience working in a GMP (GxP) environment (desirable)
  • Live no more than 30 minutes driving time from the facility (preferable)
32

Qc Associate Resume Examples & Samples

  • Perform routine testing including Facilities (Water/Gas), STAT testing (In support of Manufacturing), and sample receipt functions
  • Testing using HPLC, UV-Vis, ATKA, Sialic acid, water testing (TOC, Conductivity, and Nitrates)
  • Perform Sample Receipt functions
33

Senior Qc Associate Resume Examples & Samples

  • Develop material specifications and methods in collaboration with various functional departments such as Process Development, Manufacturing Science, Supplier Quality, and Regulatory
  • Serve as a key integral member of a material Category team and other relevant interdepartmental teams. Contribute and influence the strategy to be implemented for various material categories
  • Evaluate vendor changes to packaging components in support of the Vendor Initiated Change (VIC) program
  • Use the Trackwise system to manage change controls, discrepancies, and CAPAs
  • Develop/approve method validation protocols and reports
  • Support Drug Substance or Drug Product tech transfers as needed
  • Maintain a state of inspection readiness
  • Provide input to the development of personal performance goals and departmental objectives
  • Collaborate with Management to establish and meet targets and timelines
  • Manage competing priorities
  • Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems
  • Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Conduct global discrepancy evaluations and assessments
  • Serve as a technical subject matter expert (SME) in support of department functions
  • Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions
  • Be accountable for behaviors as described in Roche’s Values and Competencies
  • Some traveling required
  • Troubleshoot variety of technical issues
  • Provide material information as needed to customer groups (Regulatory, Process Development, etc)
  • Interpret new compendia or regulatory requirements and apply to raw material functions
34

Qc Associate Resume Examples & Samples

  • Primary responsibilities include testing of Abatacept using HPLC, UV-Vis, ATKA, Sialic acid, water testing (TOC, Conductivity, and Nitrates), and performing Sample Receipt functions
  • Participate in Tech transfer, familiar with GMP compliance
  • Requires BS with minimum of 3 years of experience in a GMP QC lab
  • Requires strong technical lab skills using pipettes, analytical balances, pH meter, Empower software, HPLC, UV-Vis, & ELISA
  • Experience with LIMS and Smart lab computer applications a plus
  • Will perform routine testing including Facilities (Water/Gas), STAT testing (In support of Manufacturing), and sample receipt functions
35

Qc Associate Resume Examples & Samples

  • Assisting in variety of activities to ensure compliance with applicable quality and regulatory requirements
  • Participate in developing, reviewing and maintaining documents to include corporate level Standard Operating Procedures to ensure quality objectives are met
  • Inspect finished goods for compliance with established quality specifications. Work with contract manufacturer, receiving, operations and materials personnel to accurately complete required QC inspection and documentation, determine correct disposition, and apply correct status labeling in SAP
  • Detect nonconforming conditions during inspection and accurately document each condition. Assess product conformity to specifications and the authority to disposition in-process materials. Provide recommendation and address nonconforming conditions and processes
  • Identifying deviations and if occur have the authority and responsibility to refuse the release of a product if not comply with SOP
  • Review, release, check, retain sampling, general inspection of all incoming material inspection and resolving production problems
  • Develop and implement process improvements within own area and work effectively with teams to identify and develop process improvements. Participate in other continuous improvement activities
  • Maintain current knowledge of the basic requirements for compliance in own area of work and comply with those requirements
  • Interacting daily contact with Operations, Packaging, Marketing, R&D and Regulatory Affair departments
  • Reviews SOPs, general documentation and provide training as needed to other employees
  • Support stability program
36

Senior Qc Associate Resume Examples & Samples

  • A minimum of 8 years of related pharmaceutical experience
  • Thorough knowledge of analytical principles, methodologies, and techniques utilized and state of the art computer application and instrumentation in the pharmaceutical QC environment
  • Thorough understanding of budgeting principles, resource management, and goals/objective setting and implementation
  • Auditing and technical report writing experience
  • Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations
  • Experience in Deviation Management
  • Experience in Change Control, Validation and APR/PQR
  • Experience with Health Authority Audits
  • Very good user knowledge for Microsoft Word and Excel, SAP and Trackwise
  • Demonstrate leadership ability and excellent inter-personal skills
37

Qc Associate Resume Examples & Samples

  • Performs test methods and procedures of cellular products
  • Performs maintenance, monitoring, and trouble-shooting of equipment
  • Tests, documents and reports results for products or materials for Clinical Trial supplies
  • Participates in managing QC materials and supplies
  • Performs and assists in equipment and method validations as needed
  • Performs reagent and media preparation
  • Provides input to trouble shoot equipment malfunctions and investigate out of specification and/or non-conforming test results
  • Initiates, investigates and prepares deviation reports and implements corrective actions, preventive actions
38

Qc Associate Resume Examples & Samples

  • A minimum of 1 year work experience in pharmaceutical and com-mercial environment is preferred
  • Previous hands-on practical laboratory experience is required
  • Must have a demonstrated working knowledge of scientific principles
  • Must be able to demonstrate basic decision-making skills
  • Must possess good oral and written communication skills
  • Must have demonstrated problem solving abilities
  • Strong organizational skills are required
  • Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus
  • Experience working in an FDA regulated environment is highly de-sired
  • Must be willing to work as part of a team and demonstrate good inter-personal skills
39

Qc Associate Resume Examples & Samples

  • Performs the accurate execution of any and/or client test methods and procedures of cellular products to ensure the Safety and/or Efficacy of different cell populations
  • Perform maintenance, monitoring, and trouble shooting of pertinent equipment
  • Test, document and report results for products or materials for Clinical Trial supplies following client procedures and CGMP & GTP
  • Successfully, perform state proficiency testing and/or client proficiency testing under direct supervision as applicable
  • Participate in managing QC materials and supplies; Ordering of materials; Manage and monitor the use of materials
  • Perform and assist in equipment and method validations as needed; Reagent and Media Preparation
  • Able to provide input based on level of knowledge and experience to trouble shoot equipment malfunctions and investigate out of specification and/or non-conforming test results
  • Initiate, investigate and prepare deviation reports with input from supervisor in a timely manner and implement corrective actions, preventive actions
  • Communicate effectively with other co-workers, departments, management and clients
  • Additional tasks as assigned by the Quality Assurance Management
  • Bachelor's Degree in a relevant field required
  • Medical Technologist license or equivalent preferred
  • MUST HAVE Quality Control applicable or related experience in a clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in a CGMP/GTP environment
  • MUST HAVE a minimum of 4 years of Flow Cytometry related experience in the pharmaceutical or biologics industry
  • Strong team-oriented, interpersonal skills are essential
  • Must be able to manage and coordinate all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
40

Qc Associate Resume Examples & Samples

  • Monitor quality control on food production line, ensures quality specifications are met, and ensures product meets specifications
  • Perform required checks and measurements for specific products being made
  • Weigh bags, check temperatures, check product bags for overall quality including leaks, and ensure labels of correct information
  • Record quality control metrics on electronic tablet or other recording methods
  • Communicate to appropriate management when problems arise
  • Perform rework of product as necessary
  • Perform visual inspection of product to meet certain specification
  • Ensure conformance to company standards and customer specifications
  • *EOE Race/Color/Religion/Sex/National Origin/Protected Veteran/Disability Status***
41

QC Associate, Analytical Development Resume Examples & Samples

  • BS/MS in a biological science with 3+ years (1+ years MS) with a background in biologics and/or cellular therapeutics
  • Hands-on experience in the performance of flow cytometry methods to characterize cells (e.g. using a Canto, LSR, Guava etc.)
  • Familiarity with data analysis/statistical software packages (e.g. FlowJo, JMP, etc.)
  • Strong communication and writing skills with demonstrated ability to work both as an individual contributor and in a dynamic team environment
  • Performance of cell culture based functional assays (e.g. target cell killing, cytokine release, etc.), q/RT-PCR, ELISA, and/or microbial methods
  • Experience in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines
  • Experience generating documents intended for use in a GxP environment or regulatory filings
  • Prior hands-on work in a GxP laboratory environment
42

QC Associate Director Resume Examples & Samples

  • Oversee release and stability of gene therapy products
  • Oversee method validations (including authoring protocols and reports)
  • Optimize and validate viral infectivity and potency assays
  • Perform and appropriately document studies under cGMP to support in process, release and stability testing of clinical and eventually commercial gene therapy viral vector substance/product
  • Prepare technical reports and summaries
  • Prepare final reports, study plans, etc., as necessary for multiple projects
  • Prepare and deliver presentations of experimental results in internal forums
  • Contribute to project progress within his/her scientific discipline
  • Contribute to/author regulatory submissions and scientific journal articles
  • Train department staff on testing and laboratory systems
  • Biochemistry test method validation for in-process, release and stability
  • Experience in designing and executing large projects/studies
  • Management experience/ability with laboratory associates or other scientific personnel
  • High level of initiative, independence, and ability to work under short time lines with limited day to day supervision
  • Expertise in aseptic growth/manipulation of human, animal, and/or insect cell lines
  • Experience in techniques for titer (eg TCID50, qPCR, expression) of conventional, attenuated, and recombinant viruses as well as purity assessments for e.g. empty particles, foreign DNA, protein, etc
  • Background in virology or molecular biology strongly preferred including sterile technique
  • Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad or Minitab)
  • Familiarity with a range of analytical technologies such as HPLC, ELISA,
  • Good written and verbal skills
  • Strong critical thinking/problem solving skills
  • Proficien in the use of analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro
  • Experience with or knowledge of Quality Control or GX
  • 1-2 direct reports; manage a group of 7-10 people
43

QC Associate, Bioassay Resume Examples & Samples

  • Perform the following based on functional area
  • Associate or Bachelor’s (preferred) degree in a scientific discipline or equivalent
  • Typically 2+ years related experience in cGMP/FDA regulated industry