QA Engineer
About The Position
Join our team as a QA Engineer supporting engineering, validation, and lifecycle activities that ensure our facility remains in a constant state of cGMP readiness. In this role, you will shape quality standards across new installations, qualification activities, and continuous improvement initiatives. What you will get: A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance‑related bonus Medical, dental and vision insurance 401(k) matching plan Life insurance, as well as short‑term and long‑term disability insurance Employee assistance programs Paid time off (PTO) Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
Requirements
- Bachelor’s degree, preferably in a scientific/technical/engineering discipline.
- Proficient experience in a pharmaceutical cGMP environment or relevant regulated industry.
- Experience reviewing or executing validation documentation (IQ/OQ/PQ/PPQ) and working within Quality Systems.
- Strong understanding of cGMP regulations, risk management tools, and equipment/utilities/automation concepts.
- Ability to collaborate cross‑functionally and communicate effectively across diverse technical teams.
- Strong analytical skills with the ability to identify issues, support investigations, and recommend solutions.
Nice To Haves
- Experience supporting audits and maintaining inspection readiness is a plus.
Responsibilities
- Review and approve engineering and validation documentation, including IQ/OQ/PQ/PPQ protocols, master plans, risk assessments, and periodic reviews.
- Partner with internal and external engineering teams to support new equipment installations and ensure all documentation meets cGMP requirements.
- Support the full validation lifecycle—from design to operation, improvement, and revalidation activities.
- Represent QA on cross-functional teams overseeing facility build and laboratory move projects, including commissioning and computerized systems validation.
- Create, review, and approve SOPs, Change Controls, CAPAs, deviations, and other GxP documentation.
- Collaborate across Manufacturing, Packaging, Engineering, MSAT, PD, QA/QC and other functions to resolve issues, implement changes, and maintain compliance.
- Participate in audits, manage quality risks, support investigations, and contribute to ongoing quality system improvements.
Benefits
- Performance‑related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short‑term and long‑term disability insurance
- Employee assistance programs
- Paid time off (PTO)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
