Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Boston, USA
Posting date: 08 Oct 2020

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

Job Responsibilities:

  • Creates and reviews GMP documentation including SOPs, Annual Product Quality Reviews, Risk assessments, Supply chain map and reports as required.
  • Support assessment of data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs.
  • Supports process lifecycle and analytical lifecycle management initiatives.
  • Facilitates stakeholders meeting and track actions to completion on QA and compliance topics / issues relating to 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.
  • 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.
  • Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.

Skills and Requirements:

  • Sc. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
  • 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.
  • Planning and organizing skills are required to plan, execute and track GMP commitments and to adjust to changing priorities.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
  • Understanding of cGMP requirements for pharmaceutical manufacturing and Quality Control.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

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.