QA Receiving Inspection (RI) Specialist II

Revance Therapeutics • Johnson City, TN

118d

About The Position

The QA RI Specialist II - Receiving Inspection is responsible for independently performing inspections, sampling, and quality assessments of incoming raw materials, APIs, excipients, and packaging components in compliance with cGMP, SOPs, and applicable regulatory requirements. This role requires demonstrated technical expertise in material inspection, data review, and supplier quality oversight. QA RI Specialist II supports timely disposition of incoming goods, leads investigation activities related to nonconforming materials, and provides mentorship and guidance to Level I inspectors. The position plays a key role in ensuring that only materials meeting established specifications are released for OTC and Rx manufacturing use, safeguarding product quality, regulatory compliance, and patient safety.

Requirements

• Minimum 3-5 years of experience in Quality Assurance, Receiving Inspection, or Quality Control within the pharmaceutical, biotechnology, or regulated industry.
• Demonstrated expertise in cGMP, GDP, supplier quality, and regulatory requirements related to raw materials and packaging components.
• Experience with ERP/QMS systems and proficiency in Microsoft Office Suite.
• Strong written and verbal communication skills with the ability to collaborate cross-functionally.
• Proven ability to mentor junior staff and lead inspection-related investigations.

Responsibilities

• Independently perform receiving inspections and sampling of packaging components according to specifications and sampling standards.
• Review and approve supplier Certificates of Analysis (CoAs), regulatory documentation, and test data for compliance prior to material release.
• Conduct visual, dimensional, and labeling inspections, including identification of recurring quality trends.
• Manage ERP/QMS transactions to ensure accurate material status assignment (Quarantine, Released, Rejected).
• Lead the initiation and documentation of nonconformance records for materials outside of specifications.
• Provide technical input during deviation investigations, CAPAs, and supplier corrective actions related to incoming materials.
• Support supplier qualification and requalification activities by compiling and presenting inspection data.
• Ensure adherence to 21 CFR Parts 210/211, ICH Q7/Q9, and company Quality Management System (QMS) standards.
• Prepare and present inspection data during internal, regulatory, and customer audits.
• Enforce GDP and data integrity requirements, ensuring inspection records are accurate, contemporaneous, and audit ready.
• Serve as a quality liaison to Supply Chain, Procurement, and QA for material-related compliance issues.
• Demonstrate proficiency in inspection methodologies, measurement tools, and acceptance sampling standards (e.g., ANSI/ASQ Z1.4).
• Provide technical guidance to junior QA Inspectors and warehouse personnel on GMP inspection and handling requirements.
• Analyze inspection trends and escalate supplier performance issues to QA leadership.
• Support root cause analysis using tools such as 5-Whys, Fishbone, or Failure Mode Analysis.
• Participate in continuous improvement initiatives for receiving inspection processes.

Benefits

• Competitive Compensation including base salary and annual performance bonus
• Paid time off, holidays, and floating holidays that can be used for whatever you choose
• Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed