Quality Assuracne Specialist III QA
- Type Contract
- Salary US$35 - US$50 per hour
- Location Cambridge, Massachusetts
- Sectors Quality Assurance (QA), Quality Assurance (QA), Regulatory Affairs (RA)
Quality Assurance Specialist III QA III
Are you looking for a position in quality assurance that will challenge you, while at the same time allow you to progress in your career? My client is in need of a quality assurance candidate to support the quality management systems that support both commercial and clinical activities for the company vaccines. In this QA role you will need to provide suggestions for the ongoing improvement of GMP compliance for the company vaccines. You will also be a big component of the QA team in the support of method validation, clinical supplies disposition, batch disposition, and raw materials. This would also include the oversight of contract facilities.
- You will be responsible for the quality oversight for the transport validation of product samples for clinical and commercial activities, as well as drug product, raw materials, and drug substance.
- You will provide support to clinical trial material disposition activities.
- You will approve internal CAPA, as well as track in site CAPA system.
- You will be responsible for the everyday interactions with contract facilities.
- You will need to ensure that GMP documentation of activities at contract facilities
- In this role you will conduct investigations into issues related to GMP or problems associated with batch records, complaints, and audits.
- It will be your responsibility to approve manufacturing and testing deviations and investigations into out of specification results.
- You will both review and approve test and batch records, you will prepare annual product reviews, and process technical complaints.
- You will conduct both internal and external audits.
- It will be your responsibility to review and approve docs for tech transfer and analytical methods and manufacturing processes.
What You Need
- BA or higher in a scientific discipline.
- You will need a minimum of 3 years experience in quality or regulatory compliance within the biologics, pharmaceuticals, vaccines, or other related industries.
- You will need experience with equipment, transport, analytical method and process validation.
- You will need experience as part of multi-functional teams.
- You need to have Good Manufacturing Practice experience as well as quality assurance experience.
- Great written and verbal communication experience.
Sthree US is acting as an Employment Business in relation to this vacancy.