What are the responsibilities and job description for the QC Asset Management Specialist position at INCOG BioPharma Services?
The Quality Control 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.
Essential 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.
Special Job 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.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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Salary : $75,000 - $85,000
