QA Associate, Manufacturing Support
Location: San Diego, CA
- Perform review of production batch records and testing records for intermediates, drug substance and drug product
- Perform review of stability data and testing records for drug product
- Perform review of Facility cleaning records and other GMP records related to facility and equipment maintenance and calibration program.
- Assist in disposition of API and Drug Product lot. Generate QA disposition form and Certificate of Analyses.
- Trend test results and investigate out of specification results.
- Provide support in disposition of raw material used in cGMP manufacturing. Implement and maintain critical material qualification program.
- Assist in conducts internal audits and reviews/analyzes data and documentation.
- Provide support for the Vendor Qualification Program with respect to components and excipients used for drug product manufacture.
- Follow SOPs and documents to work in accordance with cGMPs.
- Write and revise SOPs, qualification protocols, specifications, test methods and reports.
- Assist with training employees on GMP and CFR regulations, and specific procedures.
- Perform other related duties as assigned.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena’s 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, bio engineering, etc.).
- Three (3) to five (5) years of GMP Quality Assurance experience, preferably in an aseptic manufacturing operation.
- Knowledge of cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
- Ability to deploy quality systems within a biologics industry.
- Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
- Skill in writing to effectively communicate complex ideas and concepts.
- Knowledge of aseptic manufacturing processes and relevant sterility assurance programs.
- Knowledge of cGMP auditing practices.
- Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
- Ability to work well under pressure, multi-task, be organized and have good communication skills.