Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP)
  3. United States
Philadelphia, USA
Posting date: 11 May 2021
QA.BC.37425

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

  • Independently create and reviews GMP documentation including SOPs, Annual Product Quality Reviews, Risk assessments, Supply chain map and reports as required.
  • Lead/support assessment of data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs.
  • Lead/support process lifecycle and analytical lifecycle management initiatives.
  • Lead/facilitates stakeholders meeting and track actions to completion on QA and compliance topics / issues relating to company manufacturing and product supply including Stability review boards and Product Specification Committees.
  • Provide support for deviation, investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
  • Lead/partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc.
  • Proactively contribute to management of product quality risks ensuring they are proactively mitigated, actioned, and escalated to senior management.
  • Independently performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
  • Actively contributes to continuous improvement activities.

Skills and Requirements:

  • Demonstrated ability in decision making, problem solving and project management.
  • Excellent accuracy and attention to detail.
  • Good knowledge of relevant computer packages e.g. Excel, Word, Veeva Vault, Trackwise.
  • Planning and organizing skills are required to plan, execute and track GMP commitments and to adjust to changing priorities. Highly nimble.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
  • Excellent understanding of cGMP requirements for pharmaceutical manufacturing and Quality Control.
  • Knowledge of manufacturing and analytical processes for pharmaceutical products.
  • Knowledge of quality systems with a strong business and technical acumen would be an advantage
  • Understanding of quality risk management principles.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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