Job Description

Are you interested in Quality Assurance and eager to contribute to the development of life-saving treatments?

We have an exciting opportunity for you to work in our Quality Assurance Team supporting our site during compliance inspections, including internal and corporate audits as well as Regulatory Inspections.

Responsibilities:

Ensure that all batch related records are reviewed and approved in a timely manner for completeness, accuracy and adherence to Good Documentation Practices (GDP)Conduct final review of Seed folders and convey Seeds status to relevant departmentsCommunicating with departments with regards to documentation status; maintaining the document management system (MEDS) by assisting with the review and approval stagesResponsible for the implementation, execution and ownership of Quality Systems, including electronic document management, change control and Deviation/CAPA ManagementImplementation of global and site quality proceduresSupporting cross-functional departments to assess change control impact and ensuring their timely review, implementation and closureRaising non-conformities, technical incidents and taking suitable and appropriate corrective actionsParticipate in RCA investigations, developing robust CAPA’s or change controls to rectify the problem and prevent recurrenceMentor and coach stakeholders in cGMP practices to maintain and develop a cGMP environmentPerform internal auditsMaintain and promote a state of audit readiness

Qualifications/Skills:

Experience of working in a cGMP environment and working within a Quality Management SystemProven industry experience in Quality Assurance within the Pharmaceutical industry; experience with production of a Pharmaceutical product would be desirableA working knowledge and practical experience with the regulatory requirements for manufacture of licensed medicinal productsInternal Audit Experience desirableGood communication skills

Candidates applying, please note: This is a site based role.

Closing date for applications: 31s January 2025

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R331763