INCOG Biopharma Services in Indianapolis, IN is hiring a QC LIMS Administrator. INCOG are seeking a QC LIMS Administrator that has a passion for leading projects and processes, and is familiar with transformational, situational, and servant leadership concepts. The QC LIMS Administrator will work closely with the Director of Quality Control, QC Technical Services, and IT to help INCOG select and validate its LIMS software platform.

Additionally, the LIMS Administrator will be responsible for creating and modifying master data associated with QC instrumentation and QC test methods as well as using LIMS to generate sample labels, perform sample tracking and reconciliation, and scheduling of QC personnel and equipment.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.

Job Functions:

• Create INCOG process for generating and maintaining master data for: test methods, sample labels, stability protocols, environmental monitoring schedules, instruments and standards and reagents, and custom LIMS reports.

• Serve as primary point of contact (POC) for other INCOG departments (Supply Chain, MSAT, Project Management, Validation, Quality Assurance) needing reporting or other data from LIMS.

• Coordinate and design sampling plans and author and issue certificates of analysis templates.

• Partner with QC laboratory and IT Program Manager to ensure instrument connectivity to LIMS software both during initial procurement, as well as during changes or system upgrades.

• Act as primary point of contact (POC) for technical or system-use needs with LIMS software vendor(s) in conjunction with IT Program Manager.

• Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.

Candidate Requirements:

• Bachelor’s degree in science or information technology.

• Minimum of 5 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.

• Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, in particular deployment of validated LIMS software platforms.

• First-hand experience participating in and/or hosting audits/inspections related to Quality Control.

• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, Labvantage, PowerBI, JMP, Minitab, etc.).

Why INCOG?

• Paid time off, based on tenure

• 11 paid holidays

• 401(k) plan with company match up, vested immediately

• Choice of health & wellness plans

• FSA and HSA options

• Onsite wellness facility

• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.