Quality Control Manager
PCI Pharma Services
full-time
Posted on:
Location Type: Office
Location: Madison • Wisconsin • United States
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About the role
- Provide Quality Control oversight of all cGMP testing of raw materials, in process, product release, clean utility and environmental monitoring testing.
- Review and approve all QC related investigations (deviations, OOS/OOT, EM Investigations, etc.) both with internal and external laboratories
- Maintains good relations and communications with clients as a primary technical interface
- Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing personnel
- Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
- Working with project teams to represent Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes
- Leading customer interaction on all QC related projects including routine testing updates
- Manage and develop professional and technical skills and performance of department members
- Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary
- Supporting regulatory information requests from customers as it pertains to QC.
Requirements
- BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field
- Advanced level degree preferred
- 5+ years of Pharmaceutical or Biotechnology industry experience
- Experience in leading a commercial, aseptic drug product quality control team
- 5+ years previous QC management experience
- Experience in the Management of +5 people
Benefits
- Excellent verbal, written, and interpersonal communication skills
- Highly developed leadership capabilities to motivate and inspire teams
- Independently motivated, detail oriented and good problem-solving ability.
- Demonstrates a strong customer service orientation with effective follow through
- Driven to excellence while encouraging others to engage in process improvement and innovation
- A leader who inspires and motivates, through excellent listening skills and a willingness to mentor team members
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality ControlcGMP testinginvestigationsrisk assessmentscorrective actionroutine testingQC managementaseptic drug productregulatory complianceenvironmental monitoring
Soft Skills
communicationclient relationsteam leadershipproblem-solvinginterpersonal skillsfeedback establishmenttechnical interfaceperformance managementcollaborationcustomer interaction