QA Supervisor, External QA
PCI Pharma Services
full-time
Posted on:
Location Type: Office
Location: Bedford • New Hampshire • United States
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About the role
- Work with other departments to ensure the quality of products and compliance to internal procedures and external standards
- Provide quality oversight for client facing QA operations, including Batch Record review and final product lot disposition
- Evaluate events, deviation incidences and determine whether to escalate to an investigation
- Conduct Change Control assessments and quality review
- Approve investigations and create/monitor associated CAPAs
- Establish relationships with internal and external customers to address quality matters
- Review, develop, and improve quality system procedures
- Lead improvement projects and communicate status to management
- Manage assigned QA staff, providing feedback and development
- Assist with internal audits and supplier audits as needed
- Interface with clients on documentation and compliance concerns
Requirements
- Bachelor’s Degree in a relevant scientific discipline preferred
- Minimum of 5+ years of pharmaceutical or biotech industry experience
- Experience performing RCA, technical writing, and working with quality related investigations
- Knowledge of laboratory and production equipment and IQ/OQ/PQ
- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820)
- Some experience working with international regulations such as ICH.
- Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.)
- Familiarity with ICH Q9
- Knowledge of electronic systems including SAP, LIMS, MasterControl, Trackwise, Veeva, or electronic batch recording systems
- Microsoft Office suite knowledge and proficiency with Excel is desirable.
- Previous Supervisory experience ‘Preferred’
- ASQ certification preferred
Benefits
- Equal Employment Opportunity (EEO) Statement
- Opportunities for professional development
- Competitive rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
RCAtechnical writingquality investigationsIQ/OQ/PQFDA regulationsRisk Management ToolsFMEAHACCPPHAICH Q9
Soft Skills
quality oversightrelationship buildingcommunicationleadershipfeedbackdevelopmentproject management
Certifications
ASQ certification