Quality Assurance Specialist

2 months ago

Fremont, United States Asahi Kasei America Inc Full time
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:

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, agility and an interest in transformative action are also common attributes among our team.

Position Summary:

The Quality Assurance Compliance Specialist is responsible for ensuring that products and processes meet established quality standards and regulatory requirements. This role involves conducting audits, implementing quality control procedures, and collaborating with cross-functional teams to enhance product quality and compliance. 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 culture. The position requires diverse skill sets and will provide the opportunity to challenge an individual's abilities to perform.

Position Responsibilities:
  • QA release of raw materials in QAD ERP System.
  • Review and approve deviations, change control, complaints and CAPA (Corrective and Preventive Actions).
  • Provide training, support, and guidance to staff on quality standards and procedures.
  • Be an advocate for quality culture; drive continuous improvement and ensure Bionova's processes are compliant and inspection ready.
  • Subject matter expert quality processes and on administration activities related to Bionova's MasterControl EQMS (electronic system to manage the quality system)
  • Review and approve SOPs to ensure compliance with applicable regulations (e.g., FDA, EMA, ICH).
  • Support Supplier Quality Management qualification activities by maintaining accurate records of quality inspections, audits, and compliance reports.
  • Monitor and analyze quality metrics and KPIs (Key Performance Indicators) to identify trends, areas for improvement, and present findings to management.
  • Act as a subject matter expert on quality-related matters, providing guidance and support to internal stakeholders and drive compliance to Bionova's policies, procedures, and regulatory requirements.
  • Participate in client audits, as well as Health Authority inspections as SME and/or audit/inspection execution roles.
  • Support/conduct internal audits of BNS Departments production processes, systems, and documentation to ensure compliance with quality standards.
  • 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.
  • Business travel to support audits is required.

Qualifications:
  • Bachelors' or higher degree in life sciences, engineering or other related field
  • 3-5 years of experience working in a GMP environment with direct work on manufacturing, quality, process development, and/or quality control experience in biotechnology or pharmaceutical industries
  • Experience on biotechnology is a plus (Drug Substance manufacturing)
  • Working knowledge of cGMP regulations and guidance (e.g. 21 CFR, ANNEX 1, and ICH)
Skills
  • Well versed using Microsoft Office, SharePoint, Visio, Project, Acrobat Pro, QAD and MasterControl.
  • Able to make decisions independently with minimal supervision.
  • Strong individual contributor and team player.
  • Strong analytical and problem-solving abilities.
  • Attention to detail and a commitment to quality.
  • Excellent communication and interpersonal skills.


Compensation Range: The base compensation range for this role is between $70,000 and $85,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

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.

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