QC LIMS Administrator

$90.00/yr - $125.00/yr

INCOG Biopharma Services in Indianapolis, IN is hiring a QC LIMS Administrator. INCOG is seeking a QC LIMS Administrator with a passion for leading projects and processes, and familiarity 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.

The LIMS Administrator will also create and modify master data associated with QC instrumentation and QC test methods, use LIMS to generate sample labels, perform sample tracking and reconciliation, and schedule QC personnel and equipment.

There is a growing need globally for more CDMOs (contract development and manufacturing organizations) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing. At INCOG, we are a dedicated team striving to create meaningful experiences and a culture where everyone can thrive and succeed. We are a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, our clients, and patients.

• 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 life cycles including authoring, reviewing, approving, and retiring.

• 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, Power
  
  BI, JMP, Minitab, etc.).

• 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.

• Associate

• Full-time

• Manufacturing and Quality Assurance

• Pharmaceutical Manufacturing and Medical Equipment Manufacturing