QA Specialist - Full Time & Temporary

Bionova is a rapidly growing Contract Development and Manufacturing Organization (CDMO) specializing in biologics. The company focuses on the development and manufacturing of recombinant protein products through advanced mammalian cell culture processes. Dedicated to scientific excellence and innovation, Bionova brings together top scientific talent and equips them with state-of-the-art tools within an agile, collaborative, and energized workplace culture. This dynamic environment thrives on addressing complex client challenges and consistently exceeding client expectations. At Bionova, adaptability, transformative action, and a strong desire to serve are highly valued traits that shape the workforce and contribute to the company’s ongoing success.

The QA Specialist role at Bionova is an essential position within the Quality Assurance team, specifically supporting Quality Control and Analytical Laboratories in a fast-paced CDMO environment. This position offers a broad scope of responsibilities that require the specialist to apply diverse skill sets in quality assurance practices, with a particular emphasis on Quality Control activities. The successful candidate will actively contribute to maintaining and enhancing Quality Control capabilities through a variety of critical tasks, including investigations, self-inspection audits, and thorough analytical data review.

This role is located at Bionova's Fremont, California site, specifically in the B1 building at 3100 W. Warren Ave. Functioning within a GMP (Good Manufacturing Practice) regulated environment, the QA Specialist will play a vital role in ensuring compliance with quality systems, internal Standard Operating Procedures (SOPs), and regulatory standards. The position demands strong expertise in document management and change control procedures while supporting continuous improvements across manufacturing and analytical development functions.

The QA Specialist will be responsible for reviewing batch-related records, performing QA release of raw materials using the QAD ERP System, and evaluating compliance of manufacturing records and quality control data such as sample plans and laboratory test results. Additionally, the role includes evaluating document changes related to SOPs, Master Batch Records, and test methods to ensure they meet compliance criteria. Supporting the quality control documentation process, including reviewing deviations such as Out of Specification (OOS) reports, Corrective and Preventive Actions (CAPAs), and change controls, is a key aspect of this job.

Collaboration is essential in this role, working closely with Manufacturing, Quality Control, and Analytical Development teams to improve compliance and resolve both minor and major deviations. The QA Specialist will provide support for cGMP compliance audits of suppliers' quality systems and assist with document control processes. Furthermore, this role may involve delivering training to employees as necessary to uphold organizational standards and regulatory requirements.

In terms of physical demands, this position involves working in a combination of laboratory and office settings. The candidate must be capable of walking, standing, stooping, kneeling, and crouching, with the occasional need to independently lift or move up to 40 pounds. The role requires not only technical expertise and attention to detail but also the ability to maintain composure under tight deadlines and pressure.

The base compensation for this role ranges from $36 to $48 per hour, influenced by several factors including experience, skills, job performance, and business conditions. At Bionova, employees are supported within an environment that fosters professional growth and values effective communication and teamwork, making this an excellent opportunity for those eager to advance their careers in quality assurance within the biotechnology and pharmaceutical industries.