POSITION TITLE: Senior QA Specialist
REPORT TO: Senior Director of Quality & Regulatory
SUPERVISES/DIRECTS: QA Support Staff
Responsibilities include assistance of manufacturing QA related projects that vary in scope, complexity, and size. Assist QA manufacturing activities to ensure compliance with current GMPs.
- Manage and maintain QA records (i.e., logbooks, equipment records, specifications, procedures).
- Manage Change Control Order system.
- Responsible for Record Retention activities associated with all GMP documentation maintained by Q.A.
- Identifies and initiates quality improvements in systems and procedures.
- Provides incoming and in-process support activities as required.
- Responsible for ongoing review, design, and implementation of cGMP standards.
- Review all aspects of pharmaceutical manufacturing and identify any deficiencies.
- Create/maintain/organize manufacturing staff GMP training records.
- Supervise and maintain the deviation, investigation change control, SOP validation and batch record review systems.
- Ensure the proper storage of controlled documentation (archives, back-ups).
- Review, approve and maintain certifications related to products, manufacturing supplies, and calibration records.
- Supervise the schedule for the calibration of manufacturing equipment. This includes scheduling and verifying the performance of the calibration.
- Generate and prepare client batch record package, review batch record for completeness and accuracy.
- Develop, modify, and create new format of batch records depending upon products (clients) needs.
- Review and approve completed job folder generated by receiving department.
- Review technical information provided by client for formulation process and components capability which will be used for the preparation of the batch record.
- Verify the proper storage condition for received material such as API (active pharmaceutical ingredient) and any other excipients.
- Responsible for the release of all raw material and manufacturing supplies.
- Issue and assign the proper tests required for in-process and final process testing to the analytical laboratory.
- Audit the manufacturing supplies (critical components) retention against record, completeness, and accuracy.
- Responsible for the release of manufacturing area clearance for the initiation of new filling projects.
- Supervise shipping of final product to clients.
- Prepare batch record for various media fills.
- Responsible for the accountability of the number of vials or syringes manufactured, shipped, or retained.
- Inspect final product vials for foreign particulates.
- Responsible for the custody of final product vials and their proper storage.
- Bachelor’s Degree in Chemistry, Biology, or Biochemistry and ten (10) years of experience in the same or closely related cGMP environment.
- Demonstrated competence in QA related activities through education and experience.
- Strong working knowledge and experience of GMP regulations, quality systems, and regulatory guidance documents in the US and EU.
- Knowledge and experience in biotech/pharmaceutical Quality Systems.
- Experience in sterile product manufacturing is a must.
- Clinical manufacturing and/or commercial manufacturing experience.
- Demonstrated ability to work under minimum supervision; exhibit leadership skills to coordinate personnel and projects on various levels.
- Exceptional communication skills both in written and in verbal form.
- Demonstrated ability to multi-task effectively and adjust workload based on changing priorities.
- Demonstrated organizational skills.
- Demonstrated problem-solving and critical thinking skills.
To apply for this position, please email your resume with cover letter to email@example.com .