QA Specialist

POSITION TITLE: QA  Specialist

REPORT TO: Senior Director of Quality & Regulatory

POSITION SUMMARY:

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.

PRINCIPAL DUTIES:

  • 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.

MINIMUM QUALIFICATIONS/REQUIREMENTS:

  • Bachelor’s Degree in Chemistry, Biology, or Biochemistry and 5 -7 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 info@pyramidlabs.com .