Senior QC Compliance Specialist

INCOG BioPharma Services•Fishers, IN

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Chemistry, Biology, or related sciences
Analytical and/or microbiology experience
8+ years of experience in lab or quality roles
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.

Nice To Haves

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

Responsibilities

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.