Job Details

HTI and PAI Pharma are seeking Senior Supplier Quality Auditors (Level II) for their manufacturing facility in Greenville, SC. PAI Pharma is a leading pharmaceutical manufacturer in the United States, offering a broad portfolio of unit-dose and liquid medications. Their products are manufactured in an FDA CGMP-compliant facility.

This is a full-time, direct hire, onsite, salaried position. The salary range is approximately $80,000 - $90,000 / year, depending upon experience and education. Relocation assistance to Greenville, SC is available.

Candidates must have experience as a Supplier Quality Auditor in the pharmaceutical manufacturing industry.

*This position will require 50%+ travel (within the U.S. and internationally) and candidates must have a valid U.S. passport.*

Requirements:

• Must have a Bachelor of Science degree in Chemistry, Biology, Chemical Engineering, or other closely related major
• Must have at least 5+ years of recent experience as a Supplier Quality Auditor in the pharmaceutical manufacturing industry
• Must have strong knowledge of 21 CFR Part 210 and 211 guidelines
• Knowledge of cGMP/GDP compliance in an FDA-regulated environment
• Proficiency in quality auditing and documentation techniques to evaluate the compliance of raw material suppliers (API/CDMO)
• Knowledgeable of quality control/ microbial techniques, data integrity, ALCOA, interpretation of documentation, processes, investigations, to include all quality systems that support the Supplier to provide a product that is acceptable for use in pharmaceutical applications
• Proficient in Microsoft Office and ERP/Quality systems
• Certified Quality Analyst strongly preferred

Job Summary:

The Senior Supplier Quality Auditor ensures quality and compliance with cGMPs and internal, external, and international requirements regarding supplier qualification. Responsibilities include maintaining current supplier qualification documentation, including SAQs, Quality Agreements, Change Controls Assessments, Risk Evaluations, Audit Reports, and CAPA responses, as well as any other responsibilities related to Supplier Quality.

Job Duties:

• This position will be responsible for maintaining a comprehensive risk evaluation of pharmaceutical raw material Suppliers (CDMO and API manufacturers) and determining criticality based on a risk assessment.
• Based on the risk agreement, onsite audits and/or SAQ documentation will be determined and maintained yearly.
• Ensure product integrity, safety, and compliance as applies to Suppliers.
• Will travel to and audit Critical Suppliers.
• Participate in site audits as part of a team, auditing suppliers' manufacturing facilities, including suppliers of pharmaceutical ingredients, components, contract manufacturing (CMO), and testing products.
• Provide technical expertise regarding in-process contamination control.
• Evaluate data and /or lab work from the audit of CMO and Suppliers to assess compliance with quality system regulations (ISO, GMP, Annex I, and GLP) and SOPs.
• Review records for accuracy, consistency, and compliance with aseptic processes (during audits or documents sent in advance of scheduled audits).
• Review returned Supplier Qualification Documents to verify that documents are ready for the final review and approval. Maintain the final signatory documents in a quality assessable electronic location
• Complete a report of findings during the audit that will be a part of the final report to be discussed as part of the closing of an audit as critical, major, or minor in a timely manner.
• Follow up on audits because of investigations of non-compliant issues found during audits until resolution has been communicated.
• Gather information for internal departments of possible events with Suppliers. This will provide specific information to review during the audit.
• Maintain a current calendar of travel and companies be audited.
• If not traveling, the requirement is to be onsite at the Greenville facility.

Benefits:

• Full benefits package – Medical, Dental, Vision, EAP, 401k Match
• Onsite Wellness Center
• Tuition Reimbursement
• 13 Paid Holidays
• Progressive PTO Plan