QA Document Specialist

QA Document Specialist

02 Dec 2024
North Carolina, Sanford, 27330 Sanford USA

QA Document Specialist

Are you looking for an exciting opportunity, a rewarding, enriching, and fulfilling career, and the opportunity to grow to greater levels of success with a company that values you? Then look no further! Join Eurofins PSS: a world class company that is growing by leaps and bounds while making a difference to humanity.At Eurofins PSS, you will gain experience working in state-of-the-art laboratories, and be a part of a team that is dedicated to testing, development, and advancement of life-saving drug products to make the world a healthier and happier place to live in. Our people are our chemistry and we need talented people like you now more than ever.The purpose of this role is to author technical documents to change current processes for drug development.

Collectdetails from cross-functional departments to author change controls for components and raw materials

Enterchange controls into electronic system (QTS) and routing to departments for assessments

Trackand project manage the assessment completion

Routechange control for approval, trackand manage approvals

Tracktask completion associated with approved change control and workwith owners to ensure tasks are completed by assigned due dates

Enternew enrollment tasks into electronic system (QTS) and assigntask owners

Extendenrollment due dates when needed

Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities

Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department

Bachelor's degree in a scientific or engineering discipline or similar, with aminimum of 1 yearGMP experience

Lab experience is beneficial, but not required.

Experience with changing lab processes, SOP's, procedures, etc.

Knowledge of pharmaceutical supply chain or QA experience preferred

Strong computer skills; specificallyExcelandSAP

Able to work both independently and as a member of a cross-functionalteam in a fast-paced environment

Authorization to work in the United States indefinitely without restriction or sponsorship

Valid driver’s license and personal transportation

This is anon-lab based-role- all duties will take place in an office environment.

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance ofSanford, NCare encouraged to apply.

Excellent full time benefits including comprehensive medical coverage, dental, and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holiday

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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