QA Specialist - Full Time & Temporary

Celgard; Fremont (CA); On-site; USD 50,000 - 66,000; Full time

Job summary

Bionova Scientific LLC in Fremont, California, seeks a QA Specialist to provide Quality Assurance for quality control and analytical laboratories in a fast-paced CDMO environment.

The role focuses on quality investigations, self-inspections, document management, change control, and GMP compliance. Responsibilities include batch records review, QA release of materials, and collaboration to improve quality systems.

Qualifications

• Bachelor's or higher degree in sciences.
• 2–4 years combined manufacturing/quality control in biotech/pharma.
• Knowledge of GMP regulations (US/EU/ICH).
• Experience with QA systems and processes.
• Strong technical writing and documentation skills.
• Excellent organization and planning, with adaptability.

Responsibilities

• Perform batch-related records review.
• QA release of raw materials in QAD ERP system.
• Evaluate compliance of manufacturing and QC records (sample plans, submission forms, etc.).
• Review and evaluate document changes for SOPs, MBRs, and specs.
• Support and conduct training for employees and related processes.
• Assist audits of GMP suppliers’ quality systems and document control.

Skills

Quality Assurance

Technical writing

Documentation control

Communication

Team collaboration

Education

Bachelor's degree in sciences

Tools

SharePoint

Visio

Project

Acrobat Pro

MasterControl

Job description

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

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. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

The QA Specialist will provide Quality Assurance for Quality Control and Analytical Laboratories. Working in a fast-paced CDMO environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA expectations for QC activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual’s abilities to perform investigations, self-inspection audits, and analytical data review to maintain and expand Quality Control capabilities. In addition, the position requires someone with strong document management and change control experience in procedures used in GMP environment.

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 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

Working Conditions:

• 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.

Qualifications:

• 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.

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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.