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Proclinical is working closely with a biotechnology company who is seeking a dedicated Senior Quality Control (QC) Analyst. This role involves performing QC testing in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The successful candidate will also oversee the work of junior QC staff, assist in managing the QC laboratory, and participate in assay transfer activities. This role requires maintaining GMP compliance in the QC laboratory.
Key Responsibilities
- Establish, revise, and maintain procedures for QC testing.
- Maintain QC systems related to in-process, final drug product, and stability sample.
- Review testing data of other analysts.
- Assist with the maintenance of QC laboratory and equipment.
- Perform QC testing of raw materials, in-process, water, and product samples following SOPs.
- Review and complete documentation in accordance with cGMP.
- Assist with audits and regulatory inspections, as needed.
- Oversee sampling and storage of QC samples and maintain retain inventory.
- Coordinate shipping of samples to various locations and contract testing laboratories.
- Assist with training of others within the department within the scope of knowledge and responsibilities.
- Troubleshoot equipment and analytical methods.
- Manage technical studies performed with external companies with provision and review of reports.
Requirements
- A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
- Experience in a GLP / GMP environment.
- Computer literacy (including MS Word and Excel).
- Ability to work well with others.
- Effective communication skills.
- Good organizational skills.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
