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