Catalent Pharma is growing and we are looking to hire an experienced LIMS Administrator Specialist at our biomanufacturing side in Madison, WI. This role will report into the Quality department. The Quality department is responsible for all quality assurance and quality control functions at Catalent, Madison. The Department’s primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material, Master Cell Bank, and API release.
The LIMS Administrator Specialist position manages the administration and implementation of the LabVantage Laboratory Information Management System (LIMS) implemented at the Catalent Pharma Solutions, Madison. Responsible for providing end-user support and account administration as well as responsible for system compliance. Additionally, to lead cross-functional teams comprised of laboratory, materials management, EH&S, and Quality personnel at the Madison facility and other Catalent sites to expand and improve the use of the LIMS system and to design and implement added-value applications within the LIMS and other Global Lab Informatics environments.
The Role (daily responsibilities)
The position will perform daily work assignments accurately and in a timely and safe manner.This position will perform complex scientific work, evaluating, selecting and applying standardized scientific procedures and techniques to assignments with clear, specific objectives; assignments require investigation of a number of variables and several complex features. Extensive exercise of judgment is required on details of work and in making preliminary selections and adaptations of alternatives.
- Administer accounts and job types.
- Solve end-user LIMS template and end-user LIMS data entry issues.
- Work with IT and Quality personnel to ensure system compliance.
- Develop and execute validation scripts as needed for change control issues.
- Identify operational improvement opportunities which LIMS can provide solutions.
- Lead cross-functional teams to develop site specific needs in a harmonized format.
- Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.
- Develop and/or revise site SOPs as well as developing specific LIMS SOPs in collaboration with Vendor and the appropriate personal from each discipline.
- Prepares and maintains all SOP’s for the Laboratory directly related to assigned responsibilities.
- Is the spokesperson for the designated area regarding audits, customer visits, etc.
- All other duties as assigned.
The Candidate (requirements)
- Master's Degree in technical discipline (e.g. biology, biotechnology, engineering or business administration) or related life science with minimum of 4 years’ related experience; OR
- Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 7 years’ related experience.
- At least 4 -7 years of experience, with required degree, with the use of LIMS and/or managing a LIMS in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics).
Thorough knowledge of cGMP/ICH/FDA regulations with 21 CFR Part11 and GAMP knowledge a plus
Laboratory skills in pharmaceutical testing is a plus
Experience with laboratory instrumentation, software and interfacing is highly desired.
Strong background in Laboratory informatics and data systems
Experience with change control and software validation preferred
Strong troubleshooting ability
Ability to prioritize and successfully manage complex and competing projects
Ability to become skilled at new applications and processes quickly--broad experience with software on PC and server platforms and programming experience a plus.
Strong customer service orientation and the ability to work independently and with QC laboratory staff to maintain or enhance the system.
Excellent oral and written communication skills
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Medical, Dental, Vision and 401K are all offered from Day One of employment
- 19 days of paid time off annually + 7 paid holidays