Proclinical is currently recruiting for a LIMS Administrator with a pharmaceutical company located in King of Prussia, PA. We are seeking a talented Laboratory Management System (LIMs) Administrator to join our growing Quality team. The LIMS Administrator is responsible for all aspects of implementation and support of LIMs. This position will manage the planning, development input, validation administration and maintenance of the LIMs system.
- LabVantage experience highly desirable.
- Position will be the Quality lead and SME for the LabVantage LIMS at TEN. This role will manage the daily routine operation of the LIMS, managing system access, master data input, ensuring high quality and timely system output, and all end user requests, including troubleshooting.
- Build strong relationships and collaborate closely with our user groups that interface with LIMS. These include Quality Control, Quality Assurance, IT, Analytical Development, Manufacturing and Materials Management teams and other relevant groups to ensure the timely and compliant operation of LIMS.
- Serve as a subject matter expert in LIMS. As required, make configuration changes, manages associate change controls, recommends measures to assure compliance and may perform other projects as assigned.
- Oversee and support the management of changes to LIMS.
- Position will be responsible for maintaining the LabVantage interface for support.
Skills and Requirements:
- B.S. in a relevant discipline (computer science, medical, biochemistry, biology, biochemical engineering, or related field).
- 3-5 to years of experience with implementation and management of LIMS as system administrator and lead/system owner roles.
- Quality interface with LIMS including establishing, implementing, validating and administering.
- Knowledge of Computer System Validation and 21 CFR Part 11 compliance requirements.
- Experience with a Laboratory Information Management System and Quality Management Systems.
- Demonstrated track record with the successful support of GxP information management systems.
- Experience leading LIMS projects, including establishing user requirements, design specifications, test script preparation and execution.
- Working knowledge of cGxP regulations, ISO requirements including ICH Guidance's, GAMP guidance, working knowledge of electronic Quality Management Systems.
- Comfortable in a fast-paced, collaborative small company environment, working with minimal direction and able to adjust workload based upon changing priorities.
- Demonstrated IT experience with some focus on quality operations experience and the ability to collaborate with and effectively influence others.
- Familiarity with LabVantage LIMS or similar systems.
- Experience with analytical test equipment software validation
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.