Senior Analytical QC Technician – cGMP Lab & Method Dev

DSM-Firmenich AG; Exton, Northern (PA, KY); Hybrid; USD 50,000 - 70,000; Full time

Benefits offered by this job

Health benefits

Annual incentive pay

Retirement savings plan

Paid time off

Job summary

DSM-Firmenich AG seeks a Senior Technician Analytical QC in Exton, PA to support accurate testing and inspection of current product lines. The role collaborates with Operations and R&D to ensure quality by performing standard and nonroutine lab tests and data organization per cGMPs.

The candidate will conduct material release, maintain records, and participate in change control while contributing to ISO 9001/13485 compliant processes. A strong quality mindset is essential.

Qualifications

• Associates degree in biological or chemical sciences required; B.Sc. or M.Sc. preferred.
• Experience in QC laboratory environments and clean rooms.
• Knowledge of sampling techniques and GMP/ISO standards.

Responsibilities

• Conduct laboratory tests and inspections on raw materials, in-process, and finished products.
• Analyze and maintain all test data according to cGMPs.
• Conduct thorough batch record reviews as part of material approval process.
• Initiate NCRs as needed and execute final disposition, MRB transactions.
• Organize laboratory supplies and documentation.
• Authorized to release and transfer in-process and finished material in ERP for sale or distribution.
• Perform routine equipment maintenance and calibration on equipment.
• Conduct routine environmental monitoring on controlled areas and water systems.
• Offer suggestions on improvement of methods and implement through change control.
• Perform non-routine tests involved with method development/improvement and validation/qualification projects.
• Assist Biomaterials Manufacturing and R&D teams as needed.
• Adhere to Biomedical Quality System procedures regarding ISO 9001 and/or 13485.
• Performs OOS investigations with oversite from the Supervisor.

Skills

Laboratory testing

GMP/ISO knowledge

Data analysis

Documentation

Environmental monitoring

Education

Associate's degree in biological or chemical sciences

Bachelor's degree in related field

Master's degree preferred

Tools

MS Word

MS Excel

Outlook

ERP system

Job description

DSM-Firmenich AG seeks a Senior Technician Analytical QC in Exton, PA to support accurate testing and inspection of current product lines. The role collaborates with Operations and R&D to ensure quality by performing standard and nonroutine lab tests and data organization per cGMPs.

The candidate will conduct material release, maintain records, and participate in change control while contributing to ISO 9001/13485 compliant processes. A strong quality mindset is essential.