Associate Specialist (m/f/d) External Laboratory QC

Job Description

We are seeking a detail-oriented Associate Specialist (m/f/d) External Laboratory QC to support the quality oversight of external and contract laboratories during a maternity leave cover period starting at 1st of March for 12 months.

This role is central to ensuring that analytical data generated externally meets internal quality standards, regulatory expectations, and cGMP requirements. You will act as a key interface between internal Quality teams and external laboratories, ensuring data integrity, investigation management, and consistent quality performance.

Main tasks:

• Primary QC contact for external and contract laboratories, ensuring clear communication, quality alignment, and compliance with cGMP requirements

• SME for external laboratory analytical testing and methods, providing technical oversight and guidance on laboratory practices

• Lead and manage external laboratory investigations, including OOS, OOT, invalid results, and atypical trends, through to compliant closure

• Review, assess, and trend externally generated analytical data in accordance with cGMP and ALCOA+ data integrity principles

• Monitor and evaluate external laboratory performance, including deviation trending, KPI tracking, and quality metrics

• Support audits, inspections, and regulatory interactions related to contract laboratories, representing QC as required

Profile:

• Degree or equivalent qualification in Life Sciences, Chemistry, Biotechnology, Pharmacy, or a related scientific discipline

• Experience working in a GMP-regulated pharmaceutical or biotechnology environment

• Strong hands-on experience with external or contract laboratory management and oversight

• Solid understanding of analytical testing (biological and/or chemical) performed by third-party laboratories

• Practical experience with deviation management, CAPA, and change control, particularly involving external partners

• Experience supporting batch release activities using externally generated QC data is highly desirable

• Experience with SAP and electronic Quality Management Systems

• Proficient in English and German

Our Benefits:

• Flexible working hours (37.5 hours/week) and an attractive company pension scheme

• Competitive salary package: 13 monthly salaries + holiday pay + target bonus

• 30 days holiday entitlement

• Hybrid working model (up to 50 % remote)

• Internal training and promotion opportunities

• International co-operations

• Training on the job

• Contributing your own ideas to the process design

• Insights into the development of medicinal products

• Corporate benefits and free car parking

• Working across borders (20 days per year)

• Paid Parental Time Off (PPTO)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Required Skills:

Accountability, Accountability, Analytical Testing, Batch Releases, Biopharmaceuticals, Biopharmaceutics, Biotechnology, Chemical Analysis, Chemical Biology, Chemical Physics, Chemistry, Detail-Oriented, GMP Compliance, GMP Laboratory, Integrity Management, IS Audit, Laboratory Analysis, Laboratory Information Management System (LIMS), Nondestructive Testing (NDT), Pharmaceutical Biology, Quality Control Inspection, Quality Control Management, Quality Engineering, Quality Improvement Programs, Quality Process Development {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

02/20/2026

*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.

Requisition ID: R380689