Principal Specialist, Quality Assurance (2nd Shift)

About the role

Quality Assurance develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. It creates 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, trains operational and quality control personnel, educates business leaders on Quality policies and procedures, and ensures all products and services are properly reviewed for quality and documented.

The Principal Specialist, Quality Assurance reports to the Manager, Quality Assurance and is responsible for ensuring quality standards and procedures are followed, overseeing quality monitoring and assurance to guarantee the highest possible product quality. Activities include inspection and quality assurance to meet specifications for in‑process and finished products, and authorization to inspect products to verify required quality standards.

Responsibilities

• Inspecting and sampling of product throughout the manufacturing process.
• Establish and maintain quality control procedures.
• Assist in determining types of tests to be performed as well as documentation and reporting requirements.
• Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products.
• Champion Quality, GMP compliance and EHS/Radiation Safety practices.
• Develop and lead GMP/GDP training of all employees.
• Follows/mentors GDP/GMP requirements.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
• Assist in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations.
• Responsible for the review and dispositioning of incoming raw materials and components.
• Required to have visual acuity and color perception; near‑vision performance should be equivalent to 20/20 with no impairment of color vision or correctable to 20/20 vision with corrective lenses.
• Assure quality events are complete, accurate, and resolved in a timely manner meeting applicable quality agreements; responsible for approval of minor Quality Events.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to appropriately challenge the design, conduct, and reporting of GMP activities including metrics and annual reporting; possesses knowledge of the production process of the product.
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the GMP Quality Management System.
• Escalates complex issues to management in a timely manner.

Qualifications

Bachelor’s degree in a related field, or equivalent work experience, preferred. Advanced degree may be preferred. 4‑8 years’ experience in a related field, preferred.

Schedule

This will be a second shift position on site.

Pay

Anticipated salary range: $82,100‑$105,480. Bonus eligible: No.

Benefits

• Medical, dental and vision coverage
• Paid time off (Untracked)
• 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

Expectations

Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects; may contribute to the development of policies and procedures; works on complex projects of large scope; develops technical solutions to a wide range of difficult problems; solutions are innovative and consistent with organization objectives; completes work independently receiving general guidance on new projects; work reviewed for purpose of meeting objectives; may act as a mentor to less experienced colleagues.