Quality Assurance Specialist
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Williamsport • Pennsylvania • United States
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About the role
- The Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System.
- Responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of responsibility.
- Provide training and analytical support in the operation of the relevant GMP systems (MasterControl, SAP etc.).
- Responsible for supporting the onboarding of new hires including participation in the Induction Program and Annual GMP Training.
- Perform data analysis and reporting of Quality System Metrics internally and globally.
- Function as Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines.
- Provide Quality document control oversight on documentation and reports.
- Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
- Responsible for management of Systems Training – developing, scheduling, and performing.
- Responsible for management of Document Management Training on site – developing, scheduling, and performing.
- Support generation of data for Management Review.
- Management of Site Metrics generation (weekly and monthly) including reporting out Globally.
- Participate in Internal Audit Program.
- Support in the preparation and hosting of Third-Party Audits including audit training and control room set up.
Requirements
- Associate’s degree in engineering (industrial, chemical), manufacturing or business administration
- Minimum: 2-years of experience in plastics injection molding and/or blow molding.
- Minimum: 3 years of demonstrated experience work in a medical device or pharmaceutical manufacturing environment.
- Experience with ISO13485 or 9001
- A thorough working knowledge of quality systems such as ISO 13485. 21 CFR Part 820 and/or Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
- Must be proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint.
- Experience with Master Control and SAP would be considered an advantage.
Benefits
- Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
- We believe in giving back to help those in need in the communities where we live and work.
- Committed to creating a healthier environment and planet through our sustainability efforts.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data analysisdocument controlquality management systemsGMP systemsquality system metricstraining developmentaudit preparationquality records managementcompliance oversightdocument management
Soft Skills
analytical supportcommunicationorganizational skillstrainingguidancecollaborationattention to detailproblem-solvingleadershipparticipation
Certifications
Associate’s degreeISO 13485ISO 900121 CFR Part 82021 CFR Part 21021 CFR Part 211