QC Systems Lead

Your Role:

This QC technical support position is responsible and accountable for driving laboratory root cause investigations, proposing appropriate CAPAs, and SME support for QC database systems and data integrity compliance. Tasks can include technical review of data generated from finished products, in-process samples, stability samples, and raw material samples against cGMP compliance, approved procedures, and method validations/verifications and/or compendial requirements.

Major Position Activities & Responsibilities:

· As assigned, perform and drive in-depth laboratory investigations to completion. Determine root cause and propose appropriate CAPAs.

· Ensure QC laboratory meets compliance requirements for data integrity including instruments and their associated software and other laboratory databases (i.e. Empower and Nugenesis LMS).

· Serve as a Qualified Scientist when needed by performing an in-depth technical review of all analytical and microbiological testing performed on finished products – in-process samples, stability samples, raw material samples, ensuring compliance with GMPs.

· 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.

· Assess method reliability and trend data for inclusion in PQR/APR.

· Revise and improve analytical methods, protocols, and associated SOPs.

· Participate in and adequately represent the QC laboratories in customer and regulatory audits of the facility as the QC data integrity SME.

· Participate in and lead projects for continuous improvements in methods or method execution.

· As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.

Who You Are

Required Qualifications:

Position requires a Bachelor’s degree in chemistry or related field with a Master’s degree preferred.

· Seven years or more of pharmaceutical industry experience and six years or more of Quality Control experience required.

· Extensive experience in chromatography methods (e.g., HPLC, UPLC, GC) and technologies required. In addition, experience with UV/VIS Spectrophotometry, FTIR Spectrophotometry, and other analytical techniques will be required.

· Extensive experience in chromatography integration software (e.g., Empower, ChemStation, Chromeleon, Totalchrom).

· Experience in technical writing, communicating across organizational levels, and data analysis and trending is expected. Good interpersonal skills are a must.

Preferred Qualifications:

Master’s degree preferred

• Proven skills coaching/mentoring technical laboratory staff in a GMP/GLP laboratory environment
• Method transfer and method validation experience desired
• The position requires proven ability and skill in analyzing, understanding and presenting technical data