QA Specialist Temporary in Fremont, California

Job Title

QA Specialist

Fremont California Bionova B1 building 3100 W. Warren Ave, Fremont, CA 94538

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 the 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 from time to time based on company needs

This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching.

The employee must occasionally lift and or move up to 40 pounds independently.

Bachelors' 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 (such as US, EU, and 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

The 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.

Company

Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve.

Adaptability and an interest in transformative action are also common attributes among our team. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.