Assoc. Specialist QA (FTC)

Job Details:

Apply locations GBR – Buckinghamshire – Milton Keynes time type Full time posted on Posted 2 Days Ago job requisition id R249353

Job Description

This is a fixed term contract to September 2024 based in our Quality Team at our campus in Milton Keynes.

Position Overview

  • Reporting to the QA Compliance Manager,
  • Ensure that production operates in a fully cGMP compliant manner in accordance with the relevant corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the product and processes are fully compliant with the filed regulatory dossiers for the products supported.

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Secondary Language(s) Job Description:

Duties, Responsibilities, Activities

  • 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 departments.
  • Communicating with departments with regards to documentation status; maintaining the document management system (MEDS) by assisting with the review and approval stages.
  • Responsible for the implementation, execution and ownership of Quality Systems, including electronic document management, change control and Deviation/CAPA Management
  • Implementation of global and site quality procedures.
  • Supporting cross-functional departments to assess change control impact and ensuring their timely review, implementation and closure.
  • Raising non-conformities, technical incidents and taking suitable and appropriate corrective actions.
  • Participate in RCA investigations, developing robust CAPA’s or change controls to rectify the problem and prevent recurrence.
  • Mentor and coach stakeholders in cGMP practices to maintain and develop a cGMP environment.
  • Perform external/internal audits
  • Maintain and promote a state of audit readiness.
  • Support and develop other departments to meet GMP requirements and to be audit ready at all times.

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:Project Temps (Fixed Term)


VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:


Valid Driving License:

Hazardous Material(s):

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Job Category: Biotech
Job Type: Full Time
Job Location: Milton Keynes

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