QC Compliance Specialist
Description
The Quality Control Compliance Specialist plays a vital role on the QC team with analytical and microbiological testing experience. This role will support laboratory processing of finished product, incoming materials and stability sample release. Additionally, they will lead projects for continuous improvements in methods or method execution.
Essential Job Functions:
- Perform in-depth technical data review of all analytical and microbiological testing performed on finished products - in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs. Review includes both technical review of method performance as well as confirming data integrity elements, e.g. good documentation practices, audit trail reviews, etc.
- As assigned, perform, and drive in-depth laboratory investigations, deviations, and change controls to completion. Determine root cause and propose appropriate CAPAs.
- Provide SME support for electronic QC database systems and laboratory data integrity compliance (OpenLab etc) to support the QC laboratories.
- Perform technical writing such as drafting specifications, protocols, SOPs, templates, etc. Revise and improve analytical methods, protocols, and associated SOPs.
- Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing.
- Provide laboratory information and documentation requests to site management and customers required for regulatory filings and product import/export needs, when required.
- Review product trends and identify out-of-trend results.
- Manage and maintain Site Stability Program.
- Assess method reliability and trend data for inclusion in PQR/APR.
- Participate in and adequately represent the QC laboratories in customer and regulatory audits of the facility.
- Assist in the management of method transfers into the QC laboratory. Work with QC and QA to ensure success of these transfers.
- Participate in and lead projects for continuous improvements in methods or method execution.
- Provide support for instrument troubleshooting, instrument repair, and instrument calibrations for the QC laboratories.
- As a part of the employee's job requirements, the employee may be required to handle waste including hazardous waste. The employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.
Special Job Requirements:
- Degree in Chemistry, Biology or Life Sciences.
- 5-7 years' experience in GMP regulated industry.
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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