Quality Assurance Analyst

Lonza•Vacaville, CA

2d•$80,000 - $128,000•Onsite

About The Position

Join our team in Vacaville and ensure the integrity of critical quality documentation that supports life-saving therapies. You’ll manage change control, maintain compliance, and drive improvements that strengthen our Quality System. What you will get: The full-time base annual salary for this position is expected to range between $80,000-$128,000. 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 Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Requirements

Bachelor’s degree (B.A. or B.S.), preferably in Life Sciences, or an equivalent combination of education and experience.
Proficient experience in a Quality role within pharmaceutical/biopharmaceutical environments (or equivalent), with hands-on EDMS and change control experience.
Working knowledge of cGMP (e.g., 21 CFR Parts 210/211), FDA regulations, and ICH guidelines related to Quality Systems.
Experience with eQMS platforms (e.g., Veeva) and supporting regulatory inspections and customer audits.
Strong communication (written and verbal), organization, and decision-making skills; able to manage multiple priorities in cross-functional settings.
Proficiency in Microsoft Office (Word, Excel) and Adobe Acrobat, including advanced formatting/layout in Word.

Responsibilities

Administer and maintain the electronic document management system (EDMS), ensuring version control, traceability, and accessibility of controlled documents.
Manage document change control (new, revised, and retired documents), coordinating timely routing for review and approval.
Coordinate document review workflows and support periodic reviews to confirm continued relevance and accuracy.
Interpret and implement Quality standards across documentation processes in alignment with cGMP, FDA, and ICH expectations.
Assist in continuous improvement initiatives for document control processes and the broader Quality System.
Collaborate cross-functionally with Manufacturing, Quality Control (QC), Regulatory Affairs, and Engineering to resolve issues and drive best practices.
Maintain confidentiality for all sensitive and proprietary information.