Specialist, GMP Quality Assurance

Job Description

Reporting to the Manager, Quality Assurance, we are looking for Specialist, GMP QA who has experience in cGMP (Code of Federal Regulations 21CFR Parts 210, 211 and Part 11, EU GMP), as well as ICH Quality Guidance’s (Q9, Q10, Q11) and both USP and EP Pharmacopeia. It is preferred the successful candidate will have demonstrated the ability to work in a laboratory setting and experience interfacing with customers on quality related matters.

Key Responsibilities

The Specialist, GMP QA is responsible for the maintenance and improvement of the Quality Systems and infrastructure appropriate for compliance with GMP requirements.  The Specialist, GMP QA will own one or more of the following Quality processes: Internal Audits, Supplier Qualification and Management, Change Control, Investigations and CAPA, Risk Management.  The role has shared responsibility for reviewing data prior to it being submitted to clients.

  • Review and approve data (Certificates of Analysis) prior to release to clients, including but not limited to QC Test data, method qualification and method validation data, clinical data entered into Data transfer forms
  • Own and ensure systems used in QA are properly maintained, executed, measured and improved.
  • Provide metrics for Quality Systems for management review.  Assist in the analysis for trends that indicate improvement opportunities.
  • Assist in the performance of internal audits according to the internal audit schedule.  Assure CAPAs to address findings are completed on time by CAPA owners.
  • Assist with ad-hoc protocol, data, report, and in-lab internal audits to verify conformance to applicable SOPs, Test methods and regulatory requirements.
  • Notify management of quality/compliance trends and service failures.
  • Facilitate changes to SOPs, policies, training materials, and other documents as needed.
  • Support and participate in the regulatory inspection/ customer audit process.
  • Provide support for laboratory failure investigations.
  • Provide support for deviation investigations.
  • Provide support for Change Control, as needed.
  • Provide Materials Review and release, as needed.
  • Contribute to the supplier management process, as needed.
  • Manage the records storage and archiving process for the GMP operation.

Qualifications

  • B.S. preferred in Biochemistry, Chemistry, or a related field
  • 3-5 years’ experience
  • Excellent written and oral communication skills.
  • Cross-functional experience working across departments in an organization
  • Strong organizational skills with ability to work independently and in a team, and multi-task
  • Demonstrated Knowledge of ICH, FDA, and EMA regulatory and/or guidance documents as well as US and international pharmacopeia, as related to quality assurance activities.
  • Demonstrated Communication and Collaboration skills to effectively provide training and coaching for quality processes, update Management on key issues and risks.
  • Knowledge of the product to perform accurate quality assessments
  • Attention to detail 
  • Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions
  • Experience with Master Control a plus.
  • ASQ Auditor Certification a plus.

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