Job detail for Associate Specialist QA Strategy & Compliance (m/f/d)

Job Description

R415002 Associate Specialist QA Strategy & Compliance (m/f/d)

Our Quality Assurance department ensures that all materials and substances contained in our products are manufactured, processed, tested, packaged, stored, and delivered in compliance with our strict quality standards and all regulatory requirements. Through the close collaboration of our internal production facilities and cooperation with external manufacturers and suppliers, we create a tightly integrated global production network dedicated to reliably and punctually supplying customers and patients worldwide with products that meet high quality standards in every individual case.

This position is limited until November 2028 due to parental leave coverage.

:

• Administration in SOP and document management (MEDS, Quality Docs, Elogs, Veeva Change, and MyLearning)

• Support with archiving (reconciliation, true copy)

• Support for employees in other departments regarding QA/GMP questions and acting as a trainer for relevant DMS systems (MEDS, Quality Docs, Elogs, Veeva Change) and overarching GMP systems

• Support in the planning and execution of the CRB (Change Review Board) meetings

• Support and planning of pest control walkthroughs and maintenance of the associated WI

• Support in the preparation of pest control quarterly reports according to Topic 6.2

• Support in the preparation of incident and investigation reports according to Topic 3.5

• Support in the creation of quality KPIs

Qualifications:

• Professional experience in document management within the pharmaceutical industry or a comparable position, ideally in a regulated environment with high quality and hygiene requirements

• Very good knowledge of GMP

• Proficient in the application and administration of modern quality systems (MEDS, Quality Docs, Elogs, and MyLearning) and MS Office (including Word, Excel, PowerPoint)

• High sense of responsibility for assigned tasks, as well as initiative, strong team and communication skills, a quick grasp of concepts, and an accurate way of working

• Structured and well-organized working style

• Good written and spoken German and English skills

People with disabilities and those with equivalent status will be given preference if equally qualified.

We are proud to be a company built on the values of our diverse, talented, and committed employees. The fastest way to drive innovative developments is to bring together different ideas in an inclusive environment. We encourage our colleagues to discuss their ideas objectively and tackle problems together. We see ourselves as an equal opportunity employer and are committed to promoting inclusive, diverse workplaces.

Required Skills:

Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Complaint Management, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Technical Writing, Training and Development

Preferred Skills:

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:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/31/2026

*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.