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Associate Director of Quality Assurance
1 week ago
ProtaGene US, Inc Oklahoma City, United StatesAssociate Director of Quality Assurance (GCP/GLP) · Massachusetts · , · United States · Massachusetts · , · United States · ProtaGene is a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. From research support through ...
Senior GCP Auditor - Oklahoma City, United States - Veristat
Description
The Senior GCP (Good Clinical Practices) Auditor is responsible for conducting assigned audits per the published audit schedules.The Senior GCP Auditor will plan, conduct, report and follow up on all types of GCP audits, including internal audits, contracted audits and vendor audits.
The Senior GCP Auditor will also provide support during client audits and regulatory inspections and will support all relevant activities associated with Veristat's Quality Management System.
What we doFor more than 27 years, Veristat has built a reputation as global experts in clinical development.
760+ Rare Disease Clinical Trials supported
160+ Marketing Applications supported
In 2022 we supported 8 marketing application that received regulatory approval
The estimated hiring range for this role is $94,500 - $143,000 plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data.
Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to:
skills and experience, licensure and certifications, education, specific location and dynamic market data.
Benefits vary by location and may include:
Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans
What we look for
Bachelor's degree in Life Sciences or related field required.
RQAP GCP or similar certification strongly preferred.
5+ years of relevant GCP auditing experience in a regulated environment such as pharmaceutical, biotech or CRO or similar environment required.
Knowledgeable in relevant regulations and guidelines including 21CFR-Part11 and ICH GCP.Fluent in Microsoft SharePoint, Outlook, Word, Excel, and PowerPoint.
Prior experience with electronic Quality Management Systems preferred.
Driving/Travel requirements - Travel up to 10% (US, Canada, or International).
Ability to travel as needed to conduct investigator site audits or vendor audits, to support client audits, etc
Automated Decision Making:
All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
#LI-RD1Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Equal Opportunity Employer
Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives.
We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen.
We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace.#J-18808-Ljbffr