HTI · 1 day ago
Senior Quality Auditor
Greenville, SC
Full-time
Hybrid
Senior Level
$80K/yr - $80K/yrHTI and PAI Pharma are seeking Senior Quality Auditors for their facility in Greenville, SC. The Senior Quality Auditor ensures quality and compliance with cGMPs and internal, external, and international requirements regarding supplier qualification.
ConsultingCRMHuman ResourcesInformation TechnologyLegalLogisticsSmall and Medium Businesses
Hiring Manager
Karsyn Ivey
Responsibilities
This position will be responsible for maintaining a comprehensive risk evaluation of Suppliers 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
Travel and auditing of Critical Suppliers or Suppliers for cause will be required as part of this position
Knowledge and promotion of cGMP/GDP compliance in an FDA-regulated pharmaceutical manufacturing environment, ensuring product integrity, safety, and compliance as applies to Suppliers
Proficiency in auditing techniques to evaluate the state of compliance of a Supplier
Participates in site audits as part of a team, auditing manufacturers of facilities used to purchase pharmaceutical ingredients, components, or contract manufacturing, supplying, or testing product(s)
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
Providing 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 noncompliant issues found during audits until resolution has been communicated
Gather information for PAI site departments of possible events with the Supplier. 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
Bachelor of Science Degree required
Knowledge of GMP Documentation
Proficient in Microsoft Office Suite
Preferred
Certified Quality Analyst 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.
Founded in 1999
1001-5000 employees
H1B Sponsorship
HTI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (2)
2021 (3)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Herb Dew
CEO
John Knight
Owner & VP of Employment Solutions
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