HTI · 1 week ago
Sr. Supplier Quality Auditor (pharmaceutical)
Greenville, SC
Full-time
Onsite
Mid, Senior Level
$80K/yr - $90K/yr
5+ years expHTI and PAI Pharma are seeking Senior Supplier Quality Auditors for their manufacturing facility in Greenville, SC. The Senior Supplier Quality Auditor ensures quality and compliance with cGMPs and internal, external, and international requirements regarding supplier qualification, maintaining documentation and performing audits.
ConsultingCRMHuman ResourcesInformation TechnologyLegalLogisticsSmall and Medium Businesses
No H1B
U.S. Citizen Only
Responsibilities
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
Qualification
Required
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
Candidates must have a valid U.S. passport
This position will require 50%+ travel (within the U.S. and internationally)
Preferred
Certified Quality Analyst strongly preferred
Benefits
Full benefits package – Medical, Dental, Vision, EAP, 401k Match
Onsite Wellness Center
Tuition Reimbursement
13 Paid Holidays
Progressive PTO Plan
Company
HTI
Industrial Staffing | Professional & Skilled Hourly Recruiting | HR Services | Retention Strategies | Outplacement | Greenfield Start Ups & Expansions | Talent Management At HTI, we offer a wide range of support under the umbrella of people at work - walking beside employers to navigate the ins and outs of the employee lifecycle since 1999.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Herb Dew
CEO
John Knight
Owner & VP of Employment Solutions
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