Principal Compliance Specialist – QA Operations

Principal Compliance Specialist – QA Operations

Requirements

• High School Diploma with 10+ years of experience in a Quality and /or other CGMP related field – required.
• 2 years of experience in a Quality role.
• Working experience in external agency regulatory audits (FDA, EMA, etc.).
• Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations.
• Prior experience leading teams or projects.
• Knowledge in external agency regulations (FDA, EMA, etc.)
• Strong computer, verbal and written communication skills.
• Experience in quality systems.
• Experience in leading cross functional teams.
• Experience with Trackwise, Veeva, or equivalent system.
• Proficient in Microsoft Office.

Responsibilities

• Provide Gemba Support
• Function as shift lead including developing junior employees
• Perform batch record review
• Perform review of column packing and qualification records
• Review and sign-off on manufacturing supervisor notes
• Review and approve CRs related to EBRs (as applicable)
• Function as SME on challenges related to production requiring a quality input
• Non-conforming material discard
• Perform logbook review
• 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 logbook audits against compliance requirements
• Review CV related documentation against specification
• Perform Bulk Raw Material Release
• 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.
• Function as department lead for internal audits
• Function as CAPA owner
• Execute containment activities
• Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs.
• Function as document owner as needed
• Maintain a high level of personal compliance to the required standards
• Partner with manufacturing and support operations to ensure a culture of continuous compliance.
• May provide training to new employees
• Review of Quality Critical Alarms and NRSR
• Initiate and investigate and QA review deviations
• Provide off-hour support for batch record and logbook issuance
• Represent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA).
• Function as back-up for QA Manager
• Other activities as assigned

Preferred Qualifications

• Associate’s degree with 8+ years of experience or Bachelor’s degree with 6+ years of experience or Master’s degree with 4+ years of experience in a Quality and / or cGMP environment – preferred.
• 4+ years’ experience in a Quality Assurance role.
• Experience in bio-pharmaceutical industry.
• Capable of analyzing trends and metrics that lead to improvement.
• Strong technical writing skills.
• Effective time management, attention to detail, organizational skills, teamwork and collaboration.
• Significant capability in problem solving methodology.
• Experience working in an environment of operational excellence.
• Experience training and developing employees.
• Experience participating in external agency inspections.
• Knowledge of regulatory enforcement trends.
• Ability to work independently.