Qa Specialist

Preferred Qualifications:
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)

Functions:
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.
Note:
Overnight shift (third shift) must be available to work overtime hours

Education:
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
Job Type: Contract
Experience:
QA / Manufacturing: 5 years (Required)
Quality Auditor: 5 years (Required)

Education:
Bachelor's (Required)

Language:
Spanish & English (Required)

Contract Length:
5 - 6 months

Full Time Opportunity:
No

Additional Compensation:
Other forms

Benefits:
None

Schedule:
Monday to Friday
Night shift
Overtime

Work Remotely:
No