QA Specialist - Full Time & Temporary

Company Overview Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Job Description The QA Specialist will provide Quality Assurance for Quality Control and Analytical Laboratories in a fast‑paced CDMO environment. The role focuses on QA expectations for QC activities, including investigations, self‑inspection audits, and analytical data review to maintain and expand Quality Control capabilities. Strong document management and change control experience in a GMP environment is required. Location Fremont, California – Bionova B1 building 3100 W. Warren Ave, Fremont, CA 94538 Position Responsibilities Perform batch‑related records review. Perform QA release of raw materials in QAD ERP System. Evaluate compliance of completed manufacturing records (sample plans, sample submission forms, etc.) and quality control records (test/analytical results). Evaluate document changes for compliance requirements (SOPs, Master Batch Records, specifications, test methods, etc.). Review all supporting documents regarding Quality Control documentation including deviations (such as OOS), CAPAs, and change controls. Collaborate with Manufacturing, Quality Control, and Analytical Development to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations. Support cGMP compliance audits of GMP suppliers' quality systems. Support Document Control related processes. Support and conduct training for employees as necessary. Perform other related duties as assigned based on company needs. Working Conditions The position requires a lab/office setting with walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift or move up to 40 pounds independently. Qualifications Bachelor's or higher degree in sciences. 2‑4 years of combined manufacturing process development, manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries. 2‑4 years experience in a GMP environment. Experience in manufacturing of drug substances or drug products is a plus. Knowledge of GMP regulations and guidance (US, EU, ICH). Experience with Quality Assurance systems and processes. Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events. Strong technical writing skills. Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Master Control, a plus) and demonstrated troubleshooting and problem‑solving techniques. Ability to work under tight deadlines and pressure in a composed manner. Effective interpersonal and communication skills. Strong team player. Comfortable communicating with all levels of staff, including executives. Compensation Base compensation range for this role is $36‑$48 an hour. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business/economic conditions. #J-18808-Ljbffr