Senior Quality Control Associate

Lonza•Vacaville, CA

1d•$85,500 - $142,500•Onsite

About The Position

With limited supervision, the Vacaville Quality Control Senior Associate is responsible for the microbiological and analytical testing of in-process controls, direct materials, drug substances, and drug products for release, stability programs, and plant support while in full compliance with current cGMPs regulations and Lonza corporate principles, quality policies, standards, and core values. Execute and maintain environmental monitoring trend reports, SOP revisions, risk assessments, health authority and customer audit inquiries and continuous improvement projects. Maintains company’s right to operate and supply to patients. In conjunction with Quality Control leadership, the Sr. QC Associate influences and coaches peers and/or reports to meet departmental and organizational goals.

Requirements

Bachelor's degree in Life Sciences or a related field.
Experience with QC Microbiology and environmental monitoring
At least seven years of relevant experience in the pharmaceutical or biopharmaceutical industry.
Sound knowledge of cGMPs, CFRs, or equivalent industry regulations.
Ability to interpret Quality standards for implementation and review while making sound decisions and problem-solving.
Technical understanding to complete both routine and non-routine assignments under minimal supervision.
Strong written and verbal communication skills to clearly convey information and update managers on project status.
Capability to safely work in a laboratory setting involving chemicals, hazardous materials, and physical demands up to 40 pounds.

Responsibilities

Act as the primary owner for complex test-related processes, including robustness, training strategies, and continuous improvement initiatives.
Serve as the primary Subject Matter Expert (SME) presenter for microbiology and environmental quality control systems, data, and procedures during internal and external regulatory inspections.
Lead root cause analyses, design quality investigations, and facilitate Out of Specification (OOS) results, complaints, and CAPA initiatives.
Author, review, and approve protocols, reports, and proposed changes to quality systems, test procedures, and test methods.
Lead, and coach team to accomplish organizational goals, promote team spirit, and guide staff in cGMP applications.
Represent Quality Control on intra-site or network projects, collaborating with management to support complex, multi-site operational goals.
Drive assay transfers, validation activities, and data trend evaluations while continuously improving processes to align with Lonza Business Management Systems (LBMS).