What are the responsibilities and job description for the QC Asset Management Specialist position at Lead Candidate?
Quality Control Asset Management Specialist
INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Control Asset Management Specialist. The QC Asset Management Specialist plays a vital role on the QC team with asset procurement, qualification, and general maintenance experience. This role will support both Microbiology and Chemistry departments by identifying, procuring, and working with the INCOG Validation group in qualifying new assets/instrumentation.
Additionally, they will organize and drive annual requalification of QC assets, interface with vendors to schedule ad-hoc repairs of instrumentation, lead laboratory expansion efforts and execute change controls to support updates for instrumentation software, as needed.
This position is fully onsite, Monday to Friday.
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.
Job Functions:
- Maintain asset/instrument qualifications and re-qualifications and per site SOP’s and Vendor Service Agreements.
- Plan and Coordinate PMs and qualifications with Vendors.
- Coordinate Qualification Activities with the QA, Validation, IT departments and applicable vendors, including the facilitation of any associated Change Controls and CAPAs.
- Maintenance of Instrument Qualification procedures including lock-out / tag-out of out of service instrumentation.
- Provide training and guidance to analysts, associates, and chemists on new equipment, where applicable.
- Develops / revises QC documents within their scope of expertise.
- Assist personnel with the troubleshooting of analytical method problems within the confines of instrument related events.
- Assist in the execution of and review of qualification protocols and ensure compliance with current industry guidelines, accuracy and completeness.
Candidate Requirements:
- Degree in Chemistry, Biology or Life Sciences.
- 4 years of experience in GMP regulated industry.
- Strong analytical skills with background in instrumentation including but not limited to: HPLC, GC, SoloVPE, CE, icIEF, etc.
- Interpersonal skills to collaborate with vendors as well as educate and train QC staff.
- Knowledge and Experience with Scheduling and Planning in an analytical laboratory.
- Strong Data Review skills.
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
