Quality Assurance Auditor
As a Quality Assurance Auditor, you will conduct audits of new and existing suppliers and vendors in support of new and commercialized products, as well as internal audits. You will also be responsible for supplier corrective action reports initiated to address defective products or services.
REPORTS TO: Senior Manager, Supplier Quality
MANAGES: Has no direct reports
Essential Job Functions/Responsibilities
- Schedules and conducts quality management system audits as required by standard operating procedures and as directed by management against Athenex Corporate (ATX), Pharma Solutions (APS), and/or Pharmaceutical Division (APD) suppliers, including contract drug manufacturers, active pharmaceutical ingredient manufacturers, contract laboratories.
- Execute internal audits in accordance with an approved audit schedule, as required by standard operating procedures and as directed by management.
- Perform audits in-person, remotely, or through the evaluation of surveys/questionnaire and first-hand knowledge of the products, processes, agreements, applicable regulations, industry best practices, Athenex’s expectations, and the vendor’s or department’s audit history.
- Conduct in-person and remote audits in a professional manner with a clear agenda and the insistence to obtain the information needed, while treating the auditee as a partner in the quest to deliver first-class drug products to the patients who need them.
- Communicate the results of audits to the supplier or internal department and Athenex management through well-written, accurate and concise, technical audit reports.
- Maintain professional, open lines of communication with the vendor or department to obtain timely responses to audit observations.
- Review and assess audit responses against the severity of the observation, commitments made or implied during the audit, and the likelihood of timely implementation and effectiveness.
- Maintain supplier qualification files in paper and/or electronic form in a secure and confidential manner.
- Draft, revise, and obtain approval of quality technical agreements between Athenex and suppliers in cooperation with legal, regulatory affairs, manufacturing sciences, quality control, and quality assurance management.
- Act as a point of contact for suppliers to communicate changes and regulatory activities occurring at their site or company.
- Monitor the regulatory standing of suppliers and maintain up to date registration, certification, and accreditation documents in the supplier’s qualification file.
- Support all Athenex departments with the handling of defective products and services by acting as the point of contact with the supplier, filing formal complaints with the supplier, and communicating with Purchasing potential returns and re-orders.
- Initiate and complete Supplier Corrective Action Reports (SCARs) in a timely manner for each defective product or service for which a formal complaint has been filed with the supplier.
- Maintain professional, open lines of communication with suppliers’ complaint departments to ensure the timely completion of complaint investigations.
- Work with the supplier, incoming quality control, quality engineering, the affected departments, and Warehouse personnel to ensure that defective products are returned to the supplier.
- Assist in finding potential new suppliers who will meet the necessary quality standards.
- Track and present supplier quality metrics at management review meetings.
- Support internal audits of the Supplier Quality group.
- May perform other duties as assigned
Required Education & Experience
- Bachelor's Degree in science or technology related field (e.g., chemistry, engineering)
- Minimum of 5 years of progressive, challenging QA/QC experience in the pharmaceutical industry with at least 3 years of previous auditing experience
- CQA a plus.
- In-depth knowledge of GMP, GLP, ICH, and EU guidelines on drug substance and finished drug product manufacturing and testing.
Required Skills & Abilities
- Capable of working independently or as part of a team, and able to coordinate multiple projects.
- Must possess exceptional written and verbal communication skills.
- Strong organizational skills for prioritizing workload and responsibilities.
- Proficient with Microsoft Office and quality management system databases.
- Prolonged periods of sitting at a desk and working on a computer
- Ability to travel domestically and internationally (~25% of the time).
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.