QA Associate, Manufacturing Support - Abzena

QA Associate, Manufacturing Support

Location: San Diego, CA
Area: Quality

Current Responsibilities:

  • 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.

 

General Responsibilities:

  • 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.

 

Qualifications/Skills Required:

  • 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.
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