Quality Assurance Auditor
Company: Bio Pharma Services USA
Location: Saint Louis
Posted on: May 6, 2021
Position Summary:Responsible for performing the activities of
the Quality Assurance Department USA and its team members, to
ensure that the Quality Management System is efficiently and
effectively implemented, maintained and improved in order to meet
or exceed regulatory compliance. To also provide regulatory
guidance to the Management team, staff and Clients, to ensure
proper conduct & documentation of clinical studies in accordance
with regulatory requirements, in-house standard operating
procedures and clinical study protocols. Duties and
- Develops, directs and implements Quality Systems/Programs to
ensure compliance to company standards, Industry standards and
- Responsible for hosting/coordinating Client Audits and
- Coordinate and provide responses to Regulatory queries,
deficiency letters, and/or to inspection and Audit
- Perform audits of clinical trials for compliance with Good
Clinical Practice (GCP), Standard Operating Procedures (SOPs),
study protocols, pertinent regulations and guidelines (FDA, TGA,
- Conduct various corporate audits, including audits of equipment
maintenance, training records, computer validation and vendor
- Audit pre-study documentation, in-process activities,
end-of-study documentation and clinical study reports
- Manage the SOP Process including the identification,
development, approval, implementation, periodic review, revisions,
controls and archival of all SOPs.
- Review Protocols and Informed Consent Forms (ICF)
- Coordinate GCP training.
- Provide feedback to the QA Director regarding any Quality
issues received internally and from the sponsors, visitors or
- University degree in a scientific area, or equivalent.
- 2-4 years QA experience, preferably including audits of Phase 1
and/or BA/BE studies.
- Excellent working knowledge of ICH guidelines, GCP, FDA
regulations and guidelines
- Experience writing and reviewing Standard Operating Procedures
- Excellent hand-eye coordination, organization, multi-tasking,
communication and interpersonal skills.
Keywords: Bio Pharma Services USA, St. Louis , Quality Assurance Auditor, Accounting, Auditing , Saint Louis, Missouri
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