Senior Quality Control Analyst
Location: San Diego, CA
Overall Position Responsibilities:
This position is expected to oversee and execute the development of plans and programs for achieving and maintaining quality control of materials tested in Abzena San Diego projects. Independently monitors operations and makes decisions necessary to ensure adherence to Quality plans and requirements for Abzena San Diego. Independently analyzes and investigates adverse quality trends or conditions and initiates corrective action deemed appropriate. This position exhibits leadership skills, the ability to organize and schedule workload to satisfy regulatory and project deadlines as it relates to Quality control findings, and the ability to speak to appropriate internal and external levels as a means to convey information with authority and credibility.
Specific Position Responsibilities:
- Analyze raw materials, in-process materials, intermediates, APIs and finished products as necessary.
- Sample materials for QC testing, retains and stability.
- Independently tests stability samples, maintain 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.
- Report and investigate OOS results; determine root cause, propose and implement corrective actions as appropriate.
- Initiate and lead investigations into environmental monitoring excursions to assess any potential impact to product.
- Independently qualify and validate analytical methods for release of final product of clinical material.
- Create and revise standard test methods, specifications, method validation protocols and reports.
- Conduct 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 Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena’s strategic goals.
- Travels as needed.
- BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.).
- Minimum five (5) 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.
- Comprehensive and extensive knowledge in the full range of quality control testing and assessment in the pharmaceutical industry.
- 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.