Specialist Qa

Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of Manufacturing experience in a GMP regulated industry. Biotechnology industry experience.
* Detailed technical understanding of bio-processing unit operations
* Skilled in performance of GMP production operations
* Regulatory knowledge and interactions
* Participate and help lead cross-functional teams
* Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
* Organizational, technical writing and presentation skills
* Project management skills
* Knowledge of control charting
* Availability to support non-standard shift
* Experience in Root Cause Analysis (Fishbone, 5 Why’s, Kepner Tregoe)
Job Type: Contract
Salary: $32.00 /hour
Experience:
Root Cause Analysis: 2 years (Required)
GMP Regulated: 5 years (Required)

Education:
Bachelor's (Required)

Shifts:
Graveyard (Preferred)

Application Question:
Ishihara Test Required

Contract Length:
Varies