Quality Assurance Specialist
- US$35 - US$55 per hour
- Cambridge, Massachusetts
- Quality & Supply Chain, Quality Assurance (QA)
QA Specialist III
I am looking for a Quality Assurance Specialist with a minimum of 3 years with direct GMP experience in Biologics, Pharma, or Solid Dosing Capacity. You should be proven in both project management skills, as well as the ability to multitask. You will be the lead Quality contact for CMOs. And review as well as release activities for commercial drug product, drug substance, and finished goods.
- Your primary focus will be providing support and guidance on routine quality - related issues.
- You will be responsible for providing Quality Assurance review and disposition of commercial lots of drug substance, product and finished goods.
- Must start, monitor, as well as complete change controls related to Quality topics
- Prepare and review applicable sections of regulatory submissions
- Distribute work to Quality Assurance staff to assure timely review of batch documentation,
- Lead investigation teams and ensure proper close out and follow - up.
- Lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance.
- Create and/or review deviations and investigations to assess cGMP compliance of lots.
- 3-5 years of direct GMP experience in Pharma, Biologics or Solid Dosing Capacity.
- BA/BS (or Masters) in any Life Science discipline preferred, and/or 8+ years experience in GxP Drug Manufacturing industry.
- Microsoft office skills.
- Proven project management skills/ multitasking skills in previous roles - planning, projects etc.
- Will need to both understand and apply good working knowledge of quality and GMP principles
- Positive work attitude, must support teamwork and continuous improvement.
- Must have the ability to handle multiple tasks concurrently and in a timely fashion.
- Wrist and hand motion are required (e.g. writing, typing)
Sthree US is acting as an Employment Business in relation to this vacancy.