Location: Vacaville, CA
This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
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.
What you will get
The full-time base annual salary for this position is expected to range between $85,500 to $142,500. In addition, below you will find a comprehensive summary of the benefits package we offer:
Performance-related bonus
Medical, dental and vision insurance
401(k) matching plan
Life insurance, as well as short-term and long-term disability insurance
Employee assistance programs
Paid time off
Shift: Monday to Friday, Day Shift 0800 - 1630
What you will do
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).
What we are looking for
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.
