Analyst, QC Job Description
Analyst, QC
provides timely status reports to laboratory management on the status and effectiveness of the laboratory Installation, Qualification, calibration and maintenance programs.
Analyst, QC Duties & Responsibilities
To write an effective analyst, QC job description, begin by listing detailed duties, responsibilities and expectations. We have included analyst, QC job description templates that you can modify and use.
Sample responsibilities for this position include:
Maintenance of cGMP within an analytical laboratory
Carry out routine analysis on Finished Product and Shelf –life samples ensuring compliance with cGLP/cGMP and that turnaround times are met
Write and maintain necessary documentation (test protocols, SOPs, instrumentation manuals and checkout sheets, method transfer reports, OOS reports, ) according to the existing SOPs and cGMP standards
Documentation of results in accordance with current Good Manufacturing Practice (cGMP)
Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, ) and contractors as necessary
Test samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies
Utilize test methods derived from various compendia and non-compendial sources
Assist in sampling activities
Maintain operational and GMP readiness of the QC areas
Participate in complex projects operational excellence initiatives, and various quality systems with general supervision
Analyst, QC Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Analyst, QC
List any licenses or certifications required by the position: TS16949, AALAS, ASCP, GMP, CFCS, CFE, CPA, CAMS, PMI, LAPP
Education for Analyst, QC
Typically a job would require a certain level of education.
Employers hiring for the analyst, QC job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Chemistry, Science, Biochemistry, Biology, Microbiology, Education, Life Sciences, Associates, Technical, Molecular Biology
Skills for Analyst, QC
Desired skills for analyst, QC include:
CGMP
USP
EP
Laboratory safety practices
OSHA
DEA
Electronic laboratory management systems
FDA/PDA
Laboratory and aseptic processes
JP
Desired experience for analyst, QC includes:
Analyze samples using specific procedures and instrumentation
Recognize specification ranges
Provide assistance in troubleshooting results outside of predefined specifications
Analytical batch release data review and approval
QA review and approval of Lab non-conformances and CAPA
Familiarity with Test method validation/ tech transfer, review and approval of test method validation protocol and reports
Analyst, QC Examples
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Analyst, QC Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of analyst, QC. 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 analyst, QC
- Participate actively and contribute to teams / projects (eg
- Author technical reports and change assessments for complex functional and analytical workflows manufacturing and vendor change qualifications
- Reviews test results to ensure compliance with standards
- Performing a wide variety of activities to support the introduction of new products to the site
- Ensures lab readiness to perform raw material, in process and release testing of new clinical and commercial products
- Cordinates the transfer of analytical methods to the QC labs
- Supports lean initiatives in the area of lab operations, standard work, level loading
- Problem solving of analytical methods troubleshooting of equipment will also be performed as the employee advances from one level to the next
- Use Agile to issue Quality Incident (QI) reports
- Perform validation study or other appropriate analyses for new product or new features of the product
Qualifications for analyst, QC
- Ideally you will have worked in an R&D environment with dissolution experience
- BSc in Science - Advanced degree preferred
- Must include role(s) within a QC setting
- Process Impurity testing ELISA, Resuisudal DNA, Host Cell Protein
- Experience with liquid handling systems TECAN
- Fresh graduate and minimum equal to D1, SMAK / SMF minimum 3 years experience working preferably in a high volume and fast-paced environment, in the Pharmaceutical Industry
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Analyst, QC Job Description
Job Description Example
Our company is searching for experienced candidates for the position of analyst, QC. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for analyst, QC
- Identify problems that may affect test performance or results and conduct corrective action per protocols
- Work with R&D to transfer new products into Manufacturing
- Ensure compliance with SOPs and ISO 13485 regulation
- Assist manufacturing with production process
- Help identify and implement new process improvements
- Adhere to all processes and procedures
- Conduct training for new QA team members
- To report any out of specification or out of trend results to a supervisor and to document any deviation from written analytical procedures
- Performs automated and manual assays for Hemostasis raw materials, controls and reagents such as plasma screening final product QC testing
- Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7
Qualifications for analyst, QC
- Good working knowledge of GMP & GLP and regulatory requirements
- Understanding of medical device quality system requirements (21 CFR 820, ISO 13485, ) and appropriate application to quality control and manufacturing process change qualification, verification and validation activities
- Diploma degree from Analytical Chemistry
- Willing to be work under shift
- Complete all QC batch documentation right first time
- Degree in a relevant Science field or Equivalent
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Analyst, QC Job Description
Job Description Example
Our company is looking for an analyst, QC. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for analyst, QC
- Accurately follows established procedures and performs tasks in accordance with GMP requirements
- Investigates invalid events and troubleshoots instrumentation and methods as needed
- Initiates and supports laboratory discrepancies investigations in alignment with laboratory manager
- Supports the implementation and execution of CAPA within agreed upon timelines
- Trains other QC analysts on methods and supports method transfer and validation activities
- Supports routine 5Smethodology in laboratory to maintain a constant state of compliance and inspection readiness at all time
- Supports department improvement projects to streamline processes and improve efficiency
- Ensures that all instruments are kept in a qualified and calibrated state
- Interacts with auditors/inspectors from FDA, EMA and other regulatory agencies partners/vendors as laboratory Subject Matter Expert (SME)
- Maintains control charting for monitoring and trending of analytical method performance data
Qualifications for analyst, QC
- Minimum 2 years' work experience working within a pharmaceutical cGLP environment (IMB and FDA approved)
- 2-4 years of relevant work experience preferably Lab experience in a biotech or medically related field
- Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to bioassays in the context of biopharmaceutical product release
- Computer literate and competent in the use of corporate IT systems and Microsoft packages
- Willing to be involved in working with a team independently
- Being clear both in written and spoken communication
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Analyst, QC Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of analyst, QC. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for analyst, QC
- Day to day lab planning experience preferred
- Experience writing engineering change orders preferred
- Experience in lean production environment or lean production methodologies, such as Six Sigma or Practical Process Improvement, preferred
- Perform routine quality control testing as required and monitors or evaluates systems, equipment
- Review loan files to ensure compliance with investor guidelines, credit quality, and data integrity
- Ensure monthly audits are completed as outlined in the FAMC Quality Control Plan
- Review loans for compliance related items, such as TILA and RESPA
- Identify any potential red flags or areas of risk concern and escalate them for additional verification or investigation
- Identify, research, and report underwriting deficiencies, inconsistencies, and/or misrepresentations
- Conduct pre-funding, delinquent loan, and early payment default loan reviews
Qualifications for analyst, QC
- To ensure a safe and contamination free environment, employees who are required to enter a clean room must remove all street clothing except socks and undergarments before changing into clean room approved gowns
- Knowledge with Empower, LIMS, ELN, SDMS
- Strong working knowledge of analytical techniques, such as wet chemistry and chromatography analytical instrumentation operation, troubleshooting and maintenence
- BS in chemistry, biochemistry or related field or equivalent B.S
- Must have good knowledge and experience with HPLC techniques, experience with dissolution testing and good general chromatography knowledge
- Must have good knowledge and understanding of GMP guidelines
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Analyst, QC Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of analyst, QC. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for analyst, QC
- Builds stability studies within GQCLIMS system
- Review and monitor stability trending data on a regular basis
- Delivering training and coaching to the testing Analysts within the QC group for stability GQCLIMS
- Authors stability sections of regulatory documents and submissions
- Perform routine QC and validations on metal-conjugated antibody products for our novel mass cytometry technology on our CyTOF instruments
- Perform tissue culture for primary cells and cell lines related to the QC and validation of the antibody products
- Interface with cross functional work teams such as Customer Support/Services, Product Management, Research & Development and Sales & Marketing
- Assist with designing and executing troubleshooting experiments for projects related to customer complaints, inputs, and feedback
- Assist with validating new user protocols for reagent products improving existing protocols
- Participate in all phases of STB testing/auditing process, including analyzing requirements, developing test plans, test cases, and execution of test scripts
Qualifications for analyst, QC
- Must be able work independently within a team in a fast pace environment
- Molecular biology laboratory skills such as multichannel pipetting, qPCR, required
- BS Degree in Chemistry, Biology or other related Scientific discipline
- 0-1 year of experience with basic chemistry techniques (can be academic)
- Cannot be shy or timid - will interface with manufacturing daily
- Bachelor’s degree in Molecular Biology, Biochemistry or related Science Filed