Quality / Control Associate Job Description

Quality / Control Associate Job Description

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Quality / control associate provides leadership and guidance for laboratory cGMP compliance and maintain a high level of regulatory and safety compliance.

Quality / Control Associate Duties & Responsibilities

To write an effective quality / control associate job description, begin by listing detailed duties, responsibilities and expectations. We have included quality / control associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Maintain a safe and clean work area in accordance with OSHA safe practices
Use various Imaging tools when best applicable (Ephesoft Scan, VPD, Outlook Integration, Onbase - all versions, and/or “Drag and Drop”) to image documents received from the Preferred Bankers for New Accounts/Supersede Accounts and uploaded to Onbase accordingly
Support the clinical operations team on the review for accuracy of essential clinical documents such as clinical trials.gov entries, informed consents, investigator brochures, FDA Form 1572s
Support clinical operations team on inspection readiness documents such as trial master files and regulatory audits (FDA, EMA)
Partner with various departments in the design, testing, evaluation, and improvement of processes and controls
Collaborate with management to identify opportunities for improvement and address issues, risks, and inefficiencies
Organize process improvement initiatives ranging from simple process enhancements to larger strategic initiatives, and drive them to completion
Act as a liaison with internal departments and external service providers to ensure proper execution of responsibilities and timely delivery of work products, Identify and escalate issues to supervisor and propose recommendation for resolution
Daily review of NAV, Profit and Loss, performance, reconciliations, and client reports
Engaging in design and implementation of metrics and management tools

Quality / Control Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality / Control Associate

List any licenses or certifications required by the position: KYC, CCRC, CCRP, CCRA, CDMP, CAMS, BCSI, SOP, ISO, IDOT

Education for Quality / Control Associate

Typically a job would require a certain level of education.

Employers hiring for the quality / control associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Chemistry, Biology, Education, Life Sciences, Biochemistry, Biotechnology, Microbiology, Associates, Engineering

Skills for Quality / Control Associate

Desired skills for quality / control associate include:

Lab safety protocols
GxPs and industry guidance documents
Outlook
CGMP
MS Word
Practices
Commonly used concepts
Excel
General laboratory safety
Internet research

Desired experience for quality / control associate includes:

Ensuring that functional work
Ensuring that account events are accurately reflected and processed
Partnering with various departments in the build out, testing, and evolution of new designs, processes, reporting, and controls
Collaborating with management to identify opportunities for improvement and address issues, risks and inefficiencies
Organize and drive to completion anything from simple process enhancements to larger strategic initiatives
Acting as a liaison with internal departments and external service providers to ensure quality communication and accurate trade processing

Quality / Control Associate Examples

1

Quality / Control Associate Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality / control associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality / control associate
  • Author test methods, SOPs, work instructions for QC test methods and operation of QC work processes and systems
  • Lead the generation of method qualification protocols in collaboration with Process Development
  • Track QC projects and ensure progress is aligned with established timelines
  • Lead QC investigations and provide solutions to issues including OOS, deviations or CAPA
  • Review electronic data tables and/or data within a LIM System for accuracy, consistency, and compliance with SOPs and BPs
  • Review reagent preparation documentation for accuracy, completeness, and compliance with SOPs
  • Coordinates preventive maintenance activities for applicable equipment with outside vendors
  • Provides technical expertise and testing support to other departments as part of cross-functional project teams
  • Performs various mathematical calculations including subtraction, addition, multiplication, division, and statistical analysis including means, standard deviations, coefficient of variation (% std dev)
  • Ensure new accounts, when applicable, are linked properly to an existing Signature Card within timely manner to avoid imaging rejects
Qualifications for quality / control associate
  • Demonstrates good knowledge of computer system validation, GMP and FDA, SUP and European regulations relating to material/product samples and testing
  • Edit and review Standard Operating Procedures (SOPs)
  • Ability to maintain lab equipment including qualification and calibration
  • Technical understanding and working knowledge of contemporary molecular biology , cell biology, microbiology and/or biochemistry • Ability to operate within a clean room environment as needed
  • Technical understanding and working knowledge of contemporary molecular biology , cell biology, microbiology and/or biochemistry
  • Degree in related science area OR 4 years industry experience
2

Quality / Control Associate Job Description

Job Description Example
Our growing company is hiring for a quality / control associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality / control associate
  • Perform general QC practices and suggest solutions
  • Evaluate lab practices for compliance on a continuous basis
  • Manage the transfer and validation of analytical methods from Analytical Development to QC the transfer and validation of methods to OTL or other sites
  • Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary
  • Review of records, generation of CoAs for product release
  • Responsible for QC’s training
  • Review PVR protocols and reports, raw data, in support of viral clearance studies
  • Manage and prioritize testing and operations of QC Micro team
  • Design and oversee qualification of new microbiological techniques and equipment
  • Perform continuous improvement pertaining to water testing, lab microbiology techniques, and environmental monitoring initiatives
Qualifications for quality / control associate
  • Clear understanding of Quality Control equipment validation and maintenance, data integrity requirements
  • BS in a related science (e.g., Chemistry, Biochemistry) with minimum 5 years
  • Sound understanding of business controls
  • Stand unassisted for 6-8 hours per day
  • The successful candidate will be someone who can demonstrate the ability to coordinate multiple priorities, successfully resolve complex matters, quickly understand processes/workflows, identify risks, and effectively tailor their communication (written/verbal) to their audience They must be able to identify opportunities for process enhancements while supporting existing standards with a focus towards providing excellent service to our clients
  • Handling of physical account documentation may require lifting up to 10 pounds
3

Quality / Control Associate Job Description

Job Description Example
Our growing company is looking for a quality / control associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality / control associate
  • Maintains knowledge of key Samaritan’s Purse data entry procedures to ensure accurate clean-up of donor accounts
  • Corrects identified errors on our donor accounts, including, but not limited to, addresses, spelling, and salutations
  • Assesses accounts that have been identified as potential duplicates, following data entry procedures to determine whether they can be merged, and merges accounts if appropriate
  • Uses various Internet search tools to verify donor information
  • Maintains a clean and neat working environment at all times
  • Assist in implementing quality control standards, methods and procedures
  • Monitor and track common deviations and problem documentation, and investigate to determine root causes
  • Assist in recommending form and SOP modifications, and changes to standard protocol wording to avoid deviations
  • Assist in maintaining and revising QC documents, processes, manuals, and reports
  • Assist in updating QC guidance documents
Qualifications for quality / control associate
  • M.S./M.A
  • Diploma in Information Technology / Equivalent
  • High Certificate with Minimum 1-2 year relevant experience
  • Capable of executing work with minimum supervision
  • PhD molecular biologist or biochemist preferred with 5-7 years of Quality Control experience or MS with 10 – 12 years of Quality Control experience
  • Candidate should be well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance
4

Quality / Control Associate Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of quality / control associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality / control associate
  • Leads, develops implements and maintains quality strategies, procedures and systems in line with corporate business goals
  • QC Raw Material Group
  • QC Semi-Finished/Finished Product Group
  • Manager of QC Annual Stability Group
  • QC-IT Support
  • QC Metrology
  • Review mortgage loan documents and input of findings into numerous software systems
  • Data and loan research, document verification and exception report resolution as directed
  • Responsible for compiling information into, and extracting information from, spreadsheets and Access database forms in order to complete research and project assignments
  • Project work as assigned by Quality Control leadership
Qualifications for quality / control associate
  • Travel to other local CS office locations as required (overnight travel is <10%)
  • Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs
  • 4+ years of managerial experience, prefer more than 5 years in non-academic industry experience and/or equivalent combination of education and experience
  • Bachelor's degree from four year College or university in life science discipline
  • Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance
  • Proven industry expertise in pharmaceutical microbiology is required
5

Quality / Control Associate Job Description

Job Description Example
Our company is hiring for a quality / control associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality / control associate
  • Participates in core functions of team related to equipment & instrument projects
  • Coordinates QC lab support projects related to instrumentation & equipment with other departments
  • Ability to flex and respond to unexpected situations/demands
  • Receive and distribute incoming supplies
  • Perform GMP lot release and in-process testing for microbiology based methods such as growth promotion, gram stain, rapid sterility, and endotoxin
  • Perform Growth Promotion and Qualification of Challenge Organisms
  • Perform Water Sampling and Testing
  • Perform Gas Sampling (Viable and Non-Viable)
  • Perform environmental monitoring activities such as collecting viable air and surface EM samples, collecting non-viable particulate samples, reading of plates and trending for EM data
  • Perform routine lab cleanings, inventory checks, and material ordering
Qualifications for quality / control associate
  • Self-starter, Goal Oriented, an takes initiative
  • Must feel comfortable reporting errors to department Supervisor
  • Proficient in WMS, PMMS
  • Some experience in an industrial or research laboratory preferred
  • BS in a Biological Science-related field
  • Previous experience in QC testing and reporting

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