Title: Senior Associate Compliance
Summary: A global leading specialty generic pharmaceutical company is seeking a driven and motivated Senior Associate Compliance to lead their Billerica, MA plant. You will provide scientific support in the root cause analysis and closure of OOS and OOT investigations, product quality complaints, and ensure compliance with GLP, cGMP, and QMS standards. Do you want to help make a difference in improving people's lives through high-quality, affordable medicines? If yes, please reach out to learn more!
The Senior Associate Compliance will be responsible for…
- Compiling monthly quality metrics for internal and corporate review, including QIB meetings
- Analyzing trends to implement corrective and preventive actions to mitigate adverse trends as well as authoring and revising SOPs
- Supporting and collaborating with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS and OOT investigations
- Preparing APQR reports and statistical analysis of critical attributes for each commercial product in accordance with a predefined timeline
- Implementing and training employees for effective use of electronic Quality Management Systems, such as TrackWise, eQMS, EDMS, and LMS
The Senior Associate Compliance should have the following qualifications:
- Bachelor's Degree in Chemistry or related scientific field
- 6-8 years in a pharmaceutical manufacturing environment
- Expert knowledge of cGMP, GLP, TrackWise, eQMS, EDMS, and LMS
- Experience with instrumental and wet analytical chemistry, microbiology testing
The firm offers benefits covering medical, dental, vision, and retirement as well as programs aimed at helping you improve your own health and well-being.
- 401k company match begins day one (100% vesting immediately)
- Telehealth and behavior health services with prescription drug coverage
- Corporate discounts on entertainment and consumer goods
If you're interested in this Senior Associate Compliance role, then please don't wait to apply!