Quality Control Analyst
Location: San Diego, CA
- Analyze raw materials, in-process materials, intermediates, APIs and finished products as necessary.
- Sample materials for QC testing, retains and stability.
- Assist in testing of stability samples, keep stability program schedule, trend test results and investigate out of specification results.
- Perform routine and in-process environmental monitoring of viable air, viable surface, and total airborne particulates of the production facilities and aseptic filling operations.
- Report and investigate OOS results; determine root cause, propose and implement corrective actions as appropriate.
- Initiate and participate in the investigations into environmental monitoring excursions to assess any potential impact to product.
- Assist in qualification and validation of analytical methods for release of final product of phase II clinical material.
- Assist in writing and revising standard test methods, specifications, method validation protocols and reports.
- Assist with technical transfer of test methods for release of raw materials, in-process materials, intermediates, APIs and finished products.
- Performs other related duties as required.
- Operates to the highest ethical and moral standards.
- Complies with PacificGMP’s policies and procedures.
- Adheres to quality standards set by regulations and PacificGMP policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of PacificGMP’s business.
- Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting PacificGMP’s strategic goals.
- Travels as needed.
- BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.).
- Minimum three (3) years experience working in a lab.
- Required experience in assay development/validation.
- Required experience in optimization, development and validation of analytical and microbiological assays.
- Experience with analytical methods such as HPLC and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is a plus.
- Experience with understanding basic principles of HPLC and plate based assays such as ELISAs.
- Experience in environmental monitoring under static and dynamic conditions and personnel monitoring under GMP conditions.
- Knowledge of and experience in GMP, following STM’s, or willingness to become GMP proficient.
- Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
- Ability to use routine laboratory equipment including, but not limited to, HPLCs, plate readers and electrophoresis equipment.
- Ability to work well under pressure, multi-task, be organized and have good communication skills.