Job Description

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

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