Johnson Service Group (JSG) is currently looking for a Deviation Writer with SCAR, CAPA & SAP experience. This is a contract opportunity with a multinational pharmaceutical and biotechnology company located in Cambridge MA. This may allow 1 to 2 days hybrid but must be On Site 3 to 4 days.
Pay up to $64/hour
Job Description:
The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Supply Chain Department. The Senior Deviation/Investigation Writer will coordinate with suppliers to investigate non-conforming materials and manage supplier corrective action requests (SCAR).
Primary Responsibilities
Perform investigation activities and writing deviation investigation reports for the Supply Chain department.
Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
Write concise and accurate investigation reports.
Generate supplier corrective action requests (SCARs), and work with suppliers to investigate and close non-conforming material investigations
Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.
Initiate Change Controls as required for Supply Chain.
Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
Education and Experience
Requires a bachelor’s degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
Minimum of 3 years manufacturing or technical experience in a regulated GxP environment.
Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
Working knowledge of TrackWise, SAP or similar deviation management system.
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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