QA Receiving Inspection (RI) Specialist II

Job Summary:

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.

• Reporting to: Quality Assurance Supervisor
• Location: Johnson City, TN Manufacturing Plant
• Hours: 1st Shift

Responsibilities/Essential Duties:

Operational Execution

• Independently, 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.

Compliance & Regulatory

• 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.

Technical Expertise & Leadership

• 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.

Required Qualifications

• 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.

Physical & Work Environment Requirements

• Ability to work in controlled warehouse and sampling environments, including gowning/PPE requirements.
• Ability to stand, walk, and perform inspections for extended periods.
• May require occasional lifting of 5-40 lbs.
• Flexibility to support off-shift or weekend activities as dictated by production and supply chain needs.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• 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

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.