Development Quality Assurance Specialist II

Job Purpose

The Specialist Quality Assurance is responsible for providing support to the Quality Assurance department. This role will work with cross‑functional teams to maintain internal Quality Systems.

• Assist in the execution of Quality Systems to support GLP, GMP and GCP, including both internal and external work.
• Support internal GxP activities.
• Administer, follow‑up, write, review and approve Quality System documentation (deviations, investigations, CAPA).
• Review and help approve all GxP documentation including master batch records, labels, protocols, forms, stability data and reports.
• Assist with tracking and trending of Quality System metrics (deviations, investigations, CAPA, etc.).
• Write, review and approve SOPs and Forms.
• Help to maintain equipment related to GMP testing and manufacturing.
• Help maintain Quality’s Supplier Qualification Program.
• Help maintain other GxP programs as needed.
• Assist with internal and external audits as needed.

• BA/BS in Life Sciences.
• Minimum of 2 years GxP experience.
• Strong knowledge of MS Word and Excel.
• Excellent written and verbal communication skills.
• Must be able to work both independently and in a team situation.

Base compensation range: $95,500 to $106,000. Employees are eligible to participate in an annual performance bonus plan. Benefits include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and employee assistance program. Paid time off benefits include vacation time and sick time. At‑will employment.