QC Compliance Specialist, 3rd Shift

Quality Control Compliance Specialist

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.

Essential Job Functions:

• This position will support primarily third shift (11 pm to 7:30 am) with occasional overtime support, dependent on operations' needs.
• 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.
• Generate QC data summary documents such as certificates of analysis and stability study summary reports.
• Provide SME support for electronic QC database systems and laboratory data integrity compliance (OpenLab etc) to support the QC laboratories.
• Revise and improve technical writing documents such as analytical methods, specifications, protocols, SOPs, templates, etc.
• 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.
• 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.

Minimum Requirements:

• Bachelor's degree in Chemistry, Biology, or related sciences
• Analytical and/or microbiology experience
• 5+ years of experience in lab or quality roles

Additional Preferences:

• Advanced degree
• Experience in QC testing
• Experience with data review
• Experience in regulated industries

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.

By submitting your resume and details, you are declaring that the information is correct and accurate.