Quality Assurance Specialist — Pharmacy Distribution
- Department: Quality Assurance / Pharmacy Operations
- Reports To: Director of Quality Assurance / VP of Pharmacy Operations
- Employment Type: Full-Time, Exempt
- Location: Distribution Center / On-Site
- FLSA Status: Exempt
- Last Revised: May 2026
POSITION SUMMARY
The Quality Assurance (QA) Specialist in Pharmacy Distribution is responsible for ensuring that all pharmaceutical products handled, stored, and distributed meet established regulatory standards, organizational policies, and customer quality expectations. This role serves as a critical link between regulatory compliance, distribution operations, and pharmacy services, ensuring that every product leaving the facility is safe, effective, and properly documented.
KEY RESPONSIBILITIES
1. Quality Control & Inspection
- Conduct incoming, in-process, and outgoing inspections of pharmaceutical products to verify identity, quantity, labeling accuracy, and physical integrity.
- Perform visual inspections for damaged, expired, mislabeled, or counterfeit products and initiate appropriate holds or quarantines.
- Monitor temperature-sensitive products and cold chain compliance, including review of temperature logs and excursion investigations.
- Oversee sampling procedures in accordance with USP and internal SOPs.
2. Regulatory Compliance
- Ensure compliance with applicable federal and state regulations including FDA 21 CFR Parts 210, 211, 820; DEA requirements; and state Board of Pharmacy regulations.
- Support compliance with DSCSA (Drug Supply Chain Security Act) track-and-trace requirements, including verification of product identifiers and transaction documentation.
- Maintain awareness of USP standards (e.g., <797>, <800>, <1079>) and apply them to distribution practices.
- Assist in preparation and hosting of regulatory inspections (FDA, state BOP, DEA) and third-party audits.
3. Documentation & Record Management
- Author, review, and approve Standard Operating Procedures (SOPs), work instructions, and quality records.
- Maintain accurate and timely batch records, certificates of analysis (CoAs), deviation logs, and corrective action reports.
- Manage electronic quality management system (QMS) records and ensure document version control.
- Prepare and submit required regulatory filings and annual reports as applicable.
4. Deviation & CAPA Management
- Identify, document, and investigate quality deviations, non-conformances, and complaints.
- Lead root cause analyses (RCA) using structured methodologies (e.g., 5-Why, Fishbone/Ishikawa).
- Develop, implement, and track Corrective and Preventive Actions (CAPAs) to prevent recurrence.
- Escalate critical quality issues to QA leadership and relevant stakeholders in a timely manner.
5. Supplier & Vendor Qualification
- Conduct qualification and ongoing evaluation of pharmaceutical wholesalers, 3PLs, and suppliers.
- Review and assess supplier quality agreements and Certificates of Compliance.
- Perform on-site or remote vendor audits and document findings.
6. Training & Quality Culture
- Develop and deliver GMP/GDP training to distribution center staff, including new hire orientation and refresher training.
- Champion a culture of quality and continuous improvement across all distribution functions.
- Partner with operations, logistics, and pharmacy leadership to integrate quality into daily workflows.
7. Product Recalls & Returns
- Coordinate response to drug recalls (FDA Class I, II, III) including identification, quarantine, notification, and disposition of affected product.
- Manage returned goods processes in accordance with regulatory and company policies.
- Maintain recall readiness and participate in mock recall exercises.
QUALIFICATIONS
Education
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field required.
- PharmD, RPh licensure, or advanced degree preferred.
Experience
- Minimum 2–4 years of quality assurance experience in pharmaceutical manufacturing, distribution, or a related regulated industry.
- Experience with wholesale drug distribution (3PL, specialty pharmacy, or health system distribution) strongly preferred.
- Demonstrated experience with FDA inspections, CAPA management, and SOP authoring.
Licenses & Certifications (Preferred)
- Registered Pharmacist (RPh) or Pharmacy Technician (CPhT) license
- ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
- ISPE or PDA membership / certifications
REQUIRED COMPETENCIES & SKILLS
Technical Skills
- GDP/GMP regulatory knowledge
- DSCSA track-and-trace systems
- QMS software proficiency (Veeva, MasterControl, TrackWise)
- Cold chain & temperature monitoring
- Root cause analysis methodologies
- Statistical sampling & data analysis
- Microsoft Office / Excel proficiency
Soft Skills
- Exceptional attention to detail
- Strong written and verbal communication
- Critical thinking and problem-solving
- Ability to work cross-functionally
- Adaptable in a fast-paced environment
- High degree of professional integrity
- Proactive, continuous improvement mindset
WORKING CONDITIONS
- Primarily on-site at a pharmaceutical distribution center; some remote work may be available.
- May require standing or walking for extended periods during facility inspections.
- Occasional travel for vendor audits, regulatory meetings, or multi-site support (up to 15%).
- May work in temperature-controlled environments (refrigerated/frozen storage areas).
- Availability during off-hours may be required in the event of a recall or critical quality event.
KEY PERFORMANCE INDICATORS (KPIs)
- CAPA on-time closure rate ≥ 95%
- Deviation investigation turnaround time within defined SLA
- Audit readiness score and observation response rate
- Training completion rate across distribution staff
- Product complaint and recall response time
- Temperature excursion rate and resolution time
Apply: [email protected] | WhatsApp: +91 9137 077 377
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