Binney St
Cambridge,
MA
02142
US
2024-04-30
2024-06-15
Job Function: Engineering
Job Number: 401844
Job Description
Johnson Service Group (JSG) is currently looking for a Compliance Specialist with Root Cause Analysis and CAPA experience. This is a contract opportunity with a multinational pharmaceutical and biotechnology company located in Cambridge MA.
Pay $60/hour
The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right first-time performance. The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.
Key Responsibilities:
- Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
- Lead CAPA investigations and at times manage the implementation of CAPA.
- Own manufacturing related change controls.
- Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
- Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
- Review production documentation and perform quality walk-throughs during manufacturing events
- Participate in continuous improvement teams such as 5s, Gemba and the Production Systems (GPS).
Basic Qualifications:
- Bachelor's degree or equivalent experience.
- 3+ years of related experience.
- Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
- Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
- Good computer skills, knowledge of Microsoft office products – Word, Excel, Office.
- Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
Preferred Qualifications:
- SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single use technology (SUT), buffer preparation and filtration.
- Experience with regulatory agency interactions and inspection discussions preferred but not required.
- More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)
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Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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