Senior Quality Assurance Specialist

POSITION SUMMARYUnipac (NeilMed 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.QUALIFICATIONSBachelor’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.RESPONSIBILITIESBatch Release & Operational QAReview 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.InvestigationsLead 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.Quality SystemsSupport 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.Regulatory & Compliance SupportSupport 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.Documentation & SpecificationsReview and maintain SOPs, specifications, MMRs, and COAs.Ensure alignment between specifications, testing practices, and product requirements.Cross-Functional SupportWork closely with QC, manufacturing, and external laboratories.Provide QA oversight and ensure compliance with established procedures and standards.KEY ATTRIBUTESAble 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.Benefits401 KMedical, Dental, and Vision50k Life insurance policy paid by NeilMedAll legal PTO