This is a contract job looking for Quality Compliance Specialist w/ GMP

The Senior Quality Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team.

• Actively supports the QA Operations team by providing technical support
• Completes Phenix/Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls
• Ensure all safety requirements are being met
• Performs batch record and logbook review
• Performs review of column packing and qualification records
• Review and approve CRs related to EBRs
• Function as SME on challenges related to production requiring quality input
• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
• Issue action notices and conduct affiliated provisional release
• Conduct log book audits against compliance requirements
• Review CV related documentation against specification
• Perform media / buffer and intermediate release
• Perform release of Cell Banks for forward processing (as applicable)
• Support cross-functional internal audit activities and conduct walkthrough inspections
• Execute containment activities
• Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
• Maintain a high level of personal compliance to the required standards
• Partner with manufacturing and support operations to ensure a culture of continuous compliance

Job Type: Contract

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Monday to Friday
• Overtime

Ability to commute/relocate:

• Framingham, MA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• CAPA: 1 year (Preferred)

Shift availability:

• Night Shift (Preferred)
• Overnight Shift (Preferred)
• Day Shift (Preferred)

Work Location: One location