Senior Staff, Manufacturing Technical Operations (3)Apply Now
Location: Boston, Massachusetts 02210
Employment Type: Contract
Job Description
Contract Length: 6+ months
Job Summary: This person will have complete ownership of quality records including, but not limited to Deviations, CAPAs, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing.
Responsibilities:
Job Summary: This person will have complete ownership of quality records including, but not limited to Deviations, CAPAs, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing.
Responsibilities:
- Triage manufacturing issues in real-time on the manufacturing floor.
- Use root cause analysis tools to lead and write investigations quality events in the cell manufacturing, quality control, material operations and facility operations functional areas.
- Identify and collaborate with SMEs for triage, determine immediate actions and containment, document initial impact assessments.
- Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.
- 6+ years progressive experience in pharmaceutical development and manufacturing.
- BS in engineering, science or related discipline.
- Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
- Experience with technical writing and performing event investigations in a GMP-compliant environment.
Contact
Thomas "TJ" Medlin
Principal Recruiter
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