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Senior Quality Control Compliance Specialist Summary

The Senior 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.

• Generate QC data summary documents such as certificates of analysis and stability study summary reports.

• 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.

• Partner with clients to support onboarding, production, testing, and stability of their products through regular meetings and on-site activities.

• 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.

• Manage and maintain Site Stability Program.

• Participate in 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.

Minimum Requirements:

• Bachelor’s degree in Chemistry, Biology, or related sciences

• Analytical and/or microbiology experience

• 8+ years of experience in lab or quality roles

Additional Preferences:

• Advanced degree

• Experience in QC testing

• Experience with data review

• Experience in regulated industries

• Experience with technical writing and root cause analysis

• Experience in client relations

INCOG’s Benefits:

• Paid vacation days, amount based on tenure, and paid sick time

• 11 observed holidays

• 401(k) plan with company match up to 3.5% of salary, vested immediately

• Choice of health & wellness plans

• FSA and HSA programs

• Dental & vision care

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.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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