Specialist II, Quality Assurance
About The Position
The Quality Assurance Specialist II will implement, maintain, and champion the quality system and its components. They will operate alongside, but report separately, to laboratory operations to provide quality assurance oversight to the testing process. Responsible for the quality system and its implementation. Maintains knowledge of ISO, GMP, and other quality systems as required by clients and regulatory authorities. Responsible for equipment verification and maintenance Signs or ensures signing of required forms and checklists Initiate, distribute and review all controlled documents. Update documents as required. Ensure that no deviations are made without proper authorization and documentation. Ensures process nonconformances (PNC), deviations, change controls, and other Quality Assurance tools are appropriately completed and tracked. Assist Operations with training records, ensuring all staff training is accurate and up to date. Manage proficiency program participation and trending to ensure compliance to client, regulatory and internal requirements. Identify and ensure implementation of preventive actions. Assist with accreditation renewal, client audits and internal auditing activities. Provide training and support to Quality Assurance I.
Requirements
- Bachelor’s Degree or equivalent work experience
- 5-7 years related experience or 4+ years experiences with an advanced degree (M.S. or Ph.D.)
- Excellent organizational abilities, attention to detail, interpersonal skills and multi-tasking capability
- Knowledge of ISO, GMP, and other quality systems
- Prior experience with quality systems (document control, CAPA, OOS, etc.)
Responsibilities
- Implement, maintain, and champion the quality system and its components.
- Provide quality assurance oversight to the testing process.
- Maintain knowledge of ISO, GMP, and other quality systems as required by clients and regulatory authorities.
- Responsible for equipment verification and maintenance.
- Initiate, distribute and review all controlled documents.
- Update documents as required.
- Ensure that no deviations are made without proper authorization and documentation.
- Ensure process nonconformances (PNC), deviations, change controls, and other Quality Assurance tools are appropriately completed and tracked.
- Assist Operations with training records, ensuring all staff training is accurate and up to date.
- Manage proficiency program participation and trending to ensure compliance to client, regulatory and internal requirements.
- Identify and ensure implementation of preventive actions.
- Assist with accreditation renewal, client audits and internal auditing activities.
- Provide training and support to Quality Assurance I.
Benefits
- Medical, dental and vision insurance
- life insurance
- employee wellness programs
- Competitive pay
- 401(k) with company match (immediate vesting upon enrollment)
- employee referral program
- annual bonus target
- Online training courses
- virtual and classroom development experiences
- tuition reimbursement program
- Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
