Senior Specialist, Quality Assurance
About The Position
Quality Assurance develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. The Senior Specialist, Quality Assurance reviews cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, and production and process controls. Applying knowledge of quality concepts and technical capabilities, the Senior Specialist supports manufacturing personnel by performing line clearances and real-time review of manufacturing documentation. The Senior Specialist ensures quality events are reported, accurate and resolved in a timely manner that meets the expectations of applicable quality agreements and requirements. The role reports to the Manager, Quality Assurance and supports quality audits (internal and external) and develops actionable insights and recommendations for addressing complex quality issues.
Requirements
- 2-4 years of experience in a cGMP
- Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
Nice To Haves
- Bachelor’s of Science preferred – Chemistry or Biology degree highly preferred or previous work experience in a similar role or related field.
- Experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations is highly preferred.
- Possesses and understanding of cGMP and compliance requirements for CFR 210/211 and/or 212 and the EU is a plus.
- Experience using Veeva Vault is a plus.
Responsibilities
- Reviews cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, and production and process controls.
- Reports metrics related to products and processes.
- Establishes and maintains quality assurance procedures.
- Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
- Actively partner with site management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
- Coordinates document and record processing in eQMS system.
- Maintains GMP record retention.
- Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements and requirements.
- Ability to network across business and functional units to achieve positive outcomes.
- Able to challenge, appropriately, the design, conduct, and report GMP activities including metrics and annual reporting.
- Provides ideas for continuous improvement of the cGMP Quality Management System.
- Performs other job duties as assigned.
Benefits
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
