Senior Quality Assurance Associate

13 hours ago


Cary, North Carolina, United States Eurofins GSC Poland Sp. z o. o. Full time

Eurofins GSC Poland Sp. z o. o. is seeking a Senior Quality Assurance Professional, who will play a crucial role in ensuring the quality and integrity of our products. This exciting opportunity is based in Cary, NC, and offers an excellent salary of $96,744 per annum.

The successful candidate will have at least 10 years of experience in a GMP/GLP environment, with a minimum of 7 years in a QA role. They should possess a strong understanding of FDA requirements and quality systems, as well as good administrative skills in Microsoft Office Suite, LIMS, and QMS. A Bachelor's Degree in a scientific field is preferred.

The Senior Quality Assurance Professional will be responsible for administrative functions, data reporting, document control, equipment control, auditing, regulatory compliance, stability, and manufacturing activities as needed. They will support the administration function by acting as the Deputy QAS/QAM in their absence, monitoring quality systems deadlines, and reporting to management pending and overdue activities.

The ideal candidate will also have the ability to write, review, and approve events, CAPA, OOS/OOT, and Change Control documents. They will manage investigations, write, review, and conduct quality system, cGMP, and GLP training, participate in data analysis and reporting, and serve as a QA trainer as needed.

In addition to these responsibilities, the Senior Quality Assurance Professional will support sister sites as required, performing internal audits, supporting and hosting client and regulatory audits, conducting external audits, and reviewing and approving stability protocols.

This is a full-time position, Monday - Friday, 8:00am - 5:00pm. Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.

The benefits package includes excellent full-time benefits, including comprehensive medical coverage, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays, and more.



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