Quality Assurance Manager*in (m/w/d) Operations
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Job description
About the Position
Quality Assurance Manager*in (m/w/d) Operations
- Work Arrangement: Hybrid
- Department: Quality Assurance and Regulatory Affairs
About the Company
Join Axolabs – Where Innovation Meets Impact in RNA Therapeutics
At Axolabs, you will be part of an international team driving groundbreaking advancements in the development of nucleic acid-based medicines – from computer-aided drug development through high-throughput screening to large-scale manufacturing.
Our interdisciplinary teams combine expertise in oligonucleotide chemistry, bioinformatics, molecular biology, process engineering, analytics, and regulatory support. Whether you are a scientist, technician, data expert, or in the operational field, your work contributes to improving global health. With locations in Petaluma (USA), Kulmbach, and Berlin (Germany), and as part of the LGC Group, we offer a global, collaborative environment as a CRO and CDMO.
Responsibilities
As a Quality Assurance Manager Operations, you will:
- Support our manufacturing processes as a QA on-site: Regularly be present in production and support areas and be the first point of contact for the operational teams.
- Review and evaluate deviations, conduct root cause analyses, and follow CAPAs to completion.
- Manage change control and risk management according to our QMS and EU GMP guidelines, AMG, and AMWHV.
- Conduct batch record reviews.
- Handle and coordinate customer complaints, from root cause analysis to the implementation of measures.
- Collect and evaluate quality KPIs and derive improvements.
- Assist with audits as needed.
- Onboard and provide technical support to new colleagues in the QA team.
- Take on-call duty for GMP-relevant events. The exact scope will be determined together once production starts.
Requirements
We are looking for
- A completed scientific degree in Biology, Chemistry, Biotechnology, Pharmacy, or a comparable field, alternatively a completed vocational training in the biomedical field.
- At least 3 years of experience in a comparable QA role in the pharmaceutical industry (GMP).
- Proficiency in deviation management, CAPA, root cause analysis, and batch record review.
- Experience in pharmaceutical production and/or analytics; knowledge in chemical, biochemical, or microbiological analytics is advantageous.
- Fluency in German and English in speech and writing.
- Proficient use of MS Office.
- Strong communication skills, team spirit, reliability, and a strong sense of responsibility, even when things get hectic.
Nice to Have
- Experience with MS Office.
- Strong communication skills.
- Team spirit.
- Reliability.
- Sense of responsibility.
We Offer
- Unlimited employment contract.
- Company pension plan.
- 30 days of vacation.
- Subsidy for the Germany Ticket.
- JobRad.
- Company health management.
- Relocation support for candidates from outside the region.
- Flat hierarchies and an open corporate culture characterized by integrity, respect, passion, and curiosity.
About the Company
About LGC
LGC is a leading global life sciences company that provides mission-critical components and solutions for high-growth areas in human medicine and other markets worldwide. Our high-quality product portfolio consists of mission-critical tools for genome analysis and quality assurance applications, which are usually embedded in the products and workflows of our customers and are valued for their performance, quality, and broad spectrum.
Our Values
- Passion
- Curiosity
- Integrity
- Brilliance
- Respect
Equal Opportunity
LGC is committed to openness, mutual respect, and equal employment opportunities regardless of ethnic or social origin, gender, age, religion, any disabilities, or sexual orientation and identity. We are committed to an inclusive culture and firmly believe that the diversity of individual values and perspectives drives the success and quality of our work.
We are constantly growing and are actively looking for people who want to make a difference with passion. More information about LGC and our job openings at www.lgcgroup.com
#scienceforasaferworld
#Axolabs
Job Location
- Petaluma, USA
- Kulmbach, Germany
- Berlin, Germany
Apply Now
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