Job Description
With our new production site in Krems an der Donau, we aim to be a provider of innovative vaccines and immunotherapies for the protection and treatment of livestock and companion animals. With the further expansion of our biotechnological facilities, our company has set itself the goal of becoming a significant employer in Lower Austria, offering attractive career opportunities in a wide range of functions within a modern and safe working environment.
For this site in Krems we are looking for an:
Associate Specialist Quality Operations (m/f/d)
Full-time, immediately
Area of responsibility:
- Support in resolving problems in the production environment in accordance with existing procedures, and in implementing corrective and improvement measures
- Support for audits and inspections by authorities and internal quality functions
- Creation, review and maintenance of site-specific quality SOPs
- Participation in continuous improvement processes, MPS initiatives and projects
- Ensuring compliance with all EHS requirements at the site, including intervening in unsafe situations
- Acting as Quality Operations Representative (QRep) for operational units
- Responsibilities in document control (issuing batch documentation, batch record review)
- Responsibilities in release management (release of raw materials, preparation of batch documentation for QP Release)
- Conducting walkthroughs, quality oversight activities and the Aseptic Observer Program
Requirements:
- Completed university degree in a natural science field (e.g. chemistry, biotechnology, microbiology), a technical degree, or a comparable qualification
- Initial professional experience in the pharmaceutical industry or another heavily regulated branch of the biological or chemical industry with requirements according to EU GMP, ISO, ICH or similar
- Very good German and English skills, spoken and written
- Strong organizational skills
- Good communication skills
- Proactive and solution-oriented way of working
- High ability to work in teams and cooperate
What we offer you:
- Unique opportunity to help build a modern "state-of-the-art" production operation
- Exciting and challenging field of work n in a new, growing organization
- Flexible working hours (flexitime without core hours: framework 06:00-20:00) and the option of home office by arrangement
- Varied work in an internationally active company
- Work in a professional, ambitious and highly motivated team and an appreciative, positive working environment
- Good training and further education opportunities
- Flexible working hours and attractive social benefits
- Paid parental leave for mothers and fathers of 12 weeks
The collectively agreed minimum gross salary for this position is EUR 48,482.84 per year. Depending on the qualification profile and professional experience of the successful candidate, we are willing to pay above this minimum.
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 views objectively and to tackle problems together. We see ourselves as an employer of equal opportunity and are committed to creating inclusive, diverse workplaces.
Additional location(s) Compensation Information:
Required Skills:
Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Change Controls, Cleaning Equipment, Complaint Management, Controls Management, Decision Making, Deviation Management, Document Archiving, Documentation Maintenance, Document Controls, Document Management, Good Manufacturing Practices (GMP), Operational Excellence, Operational Quality, Process Improvements, Quality Assurance Processes, Quality Auditing, Quality Compliance, Quality Management Standards, Quality Management Systems (QMS), Quality Reporting, Quality Standards {+ 9 more}
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:
Regular
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):
BSL-2 area
Job Posting End Date:
11/4/2026
*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.