Senior QC 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 supports laboratory processing of finished product, incoming materials, and stability sample release. Additionally, they 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.
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.
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.
Handle waste including hazardous waste. Attend mandatory annual hazardous waste training meeting(s) and pass the 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.
Qualified Applicants
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.