Job Description
To strengthen the Quality Operations team at our pharmaceutical manufacturing site in Friesoythe, we are looking for an Associate Specialist Quality (m/w/d) on a full-time, fixed-term basis of 1.5 years, starting immediately.
Responsibilities:
- Quality representative for qualification and validation activities in cooperation with other departments at the site, as well as for deviations, CAPAs, SOPs, changes, logbooks (eLogs) or test methods
- Processing and investigation of incoming customer complaints
- Performing Batch Record Review, logbook checks and review of printouts from recording devices
- Performing Quality Oversight in all operational areas and during Mediafill and aseptic process simulation
- Representing Quality Assurance in various meetings and projects
Requirements:
- Completed university degree in a natural science with professional experience in pharmaceutical production / quality assurance, or several years of professional experience in a comparable position
- Very good knowledge of pharmaceutical production in the context of equipment qualification and process validation, as well as handling of deviations and changes
- Good knowledge of GMP requirements and pharmacopoeias (Ph.Eur., USP)
- Quick comprehension and the ability to work under pressure
- Confident demeanour in a cross-functional team, and the ability to make decisions quickly and in a disciplined manner
- Very good German and English skills, spoken and written
Benefits:
- Flexible working hours (37.5 hours / week)
- Attractive compensation package: 13 monthly salaries, target bonus and future amount
- Attractive company pension scheme including long-term care insurance
- 30 days of annual leave plus holiday pay (1,200 € annually)
- Corporate benefits and workplace health management
- Subsidy for bicycle leasing and fitness membership (Hansefit)
- Internal training and development opportunities, including training on the job
We are proud to be a company built on the values of its diverse, talented and committed employees. The fastest way to advance innovative developments is to bring different ideas together in an inclusive environment. We encourage our colleagues to discuss their ideas objectively and to tackle problems together. We see ourselves as an equal opportunity employer and are committed to promoting inclusive, diverse workplaces.
Additional location(s) Compensation Information:
Required Skills:
Adaptability, Adaptability, Analytical Problem Solving, Aseptic Manufacturing, Auditing, Audit Trails, Batch Production Records, Batch Record Review, Complaints Investigation, Customer Complaint Management, Customer Complaint Resolution, Data Analysis, Decision Making, Environmental Monitoring, Equipment Qualification, GMP Compliance, Laboratory Instrumentation, Laboratory Operations, Laboratory Testing, Manufacturing Processes, Operational Quality, Process Equipment, Process Verification, Product Quality Assurance, Quality Assurance Processes {+ 8 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:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/29/2026
*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.