Senior Quality Assurance Specialist

Unipac (Neil Med Pharmaceuticals) is searching for a hands‑on Sr. QA Specialist to support a high‑volume pharmaceutical manufacturing environment. This position requires a dynamic, experienced professional capable of independently managing batch review, investigations, and quality systems with minimal training. The individual must be able to make sound, risk‑based decisions and produce clear, defensible documentation.

• Bachelor’s degree in a scientific discipline required.
• 5–7+ years of QA experience in pharmaceutical manufacturing (Rx or OTC required).
• Direct experience with batch record review, product disposition, and investigation systems.
• Experience with FDA inspections, 483 responses, and/or Warning Letter remediation preferred.
• Strong working knowledge of cGMP (21 CFR 210/211) and data integrity principles.
• Ability to work independently, prioritize effectively, and operate in a fast‑paced environment.

• Review executed batch manufacturing and packaging records for completeness and compliance.
• Support batch disposition decisions, including identification of critical vs. non‑critical issues.
• Interface with internal and external quality stakeholders to resolve batch‑related observations.
• Ensure all batch documentation is complete, accurate, and inspection‑ready.

• Lead and author deviation, OOS, and non‑conformance investigations.
• Perform structured root cause analysis and ensure conclusions are scientifically supported.
• Develop and implement CAPAs, including effectiveness verification.
• Support investigations involving laboratory data, manufacturing processes, and external testing.

• Support and maintain: CAPA system, Deviation/NCR system, Change Control, and Complaint Handling.
• Ensure systems are consistently executed, well‑documented, and audit‑ready.
• Support internal audits and follow‑up activities.

• Support preparation of regulatory responses and quality documentation as needed.
• Participate in inspection readiness activities and internal assessments.
• Ensure documentation is clear, accurate, and aligned with regulatory expectations.

• Review and maintain SOPs, specifications, MMRs, and COAs.
• Ensure alignment between specifications, testing practices, and product requirements.

• Work closely with QC, manufacturing, and external laboratories.
• Provide QA oversight and ensure compliance with established procedures and standards.

• Able to contribute immediately with minimal onboarding.
• Strong technical writing skills for investigations and quality records.
• Demonstrated ability to identify true root cause and drive resolution.
• Comfortable making decisions in a dynamic operating environment.
• Willing to challenge issues and ensure compliance is maintained.
• 401 K
• Medical, Dental, and Vision
• 50k Life insurance policy paid by Neil Med