Quality Assurance Specialist

1 week 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.

  • Quality Assurance Specialist

    3 days ago

    Fremont, California, United States Asahi Kasei America Inc Full time

    Job Title: Quality Assurance SpecialistAsahi Kasei America Inc is seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring that products and processes meet established quality standards and regulatory requirements.Job Summary:The Quality Assurance Specialist will be responsible for...

  • Quality Assurance Specialist

    6 days ago

    Fremont, California, United States Tek Support Full time

    Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team at Tek Support in Alameda, CA. The ideal candidate will play a key role in ensuring product quality and compliance with regulatory requirements in the medical device industry.Responsibilities:Regulatory Compliance: Ensure compliance with FDA, ISO 13485,...

  • Quality Assurance Specialist

    1 month ago

    Fremont, California, United States Hyve Solutions Full time

    Hyve Solutions is a leading provider of innovative technology solutions dedicated to supporting customers, business partners, and employees in achieving shared goals.Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for conducting inspections, performing...

  • Quality Assurance Specialist

    4 weeks ago

    Fremont, California, United States Abbott Full time

    About the RoleThis is an exciting opportunity to join Abbott's Diabetes Care division as a Quality Assurance Specialist. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesLead and support internal and external audits to maintain compliance with regulatory...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States QAPEL MEDICAL INC Full time

    Job Title: Quality Systems SpecialistWe are seeking a highly motivated and detail-oriented Quality Systems Specialist to join our team at Q'Apel Medical Inc. This role will play a critical part in ensuring the quality and compliance of our medical devices.Key Responsibilities:Process Engineering Change Notices (ECOs) and other Quality Management System...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States Asahi Kasei Full time

    Job DescriptionBionova, a subsidiary of Asahi Kasei Medical, is seeking a Quality Assurance Compliance Specialist to join our team. As a rapidly growing biologics CDMO, we are committed to developing and manufacturing recombinant protein products using mammalian cell culture processes.Key ResponsibilitiesEnsure products and processes meet established quality...

  • Warehouse Quality Assurance Specialist

    4 weeks ago

    Fremont, United States NESCO Inc Full time

    Job Summary: We are seeking a detail-oriented Warehouse Quality Assurance Specialist to join our team at Nesco Inc. As a key member of our quality control team, you will play a crucial role in ensuring our products meet the highest quality standards.Responsibilities:Conduct thorough visual inspections of incoming and outgoing products to ensure they meet our...

  • Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Supernal Full time

    About SupernalSupernal is an Advanced Air Mobility company that's pushing the boundaries of human possibility. We're developing an electric vertical take-off and landing (eVTOL) vehicle and the ground-to-air ecosystem to support the emerging industry.Job SummaryWe're seeking a Senior Quality Engineer to join our dynamic team. As a key member of our Quality...

  • Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Supernal Full time

    About the RoleWe are seeking a highly skilled Senior Quality Engineer to join our team at Supernal. As a key member of our Quality Assurance organization, you will play a critical role in ensuring the quality and reliability of our products and processes.Key ResponsibilitiesDevelop and implement quality plans, inspection and test methods, and procedures to...

  • Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Supernal Full time

    About the RoleWe are seeking a highly skilled Senior Quality Engineer to join our team at Supernal. As a key member of our Quality Assurance organization, you will play a critical role in ensuring the quality and reliability of our products and processes.Key ResponsibilitiesDevelop and implement quality plans, inspection and test methods, and procedures to...

  • Quality Assurance Specialist

    2 days ago

    Fremont, California, United States Info Way Solutions Full time

    Quality Engineer III Job DescriptionWe are seeking a highly skilled Quality Engineer III to join our team at Info Way Solutions LLC. As a Quality Engineer III, you will be responsible for ensuring the quality of our software products and services.Key Responsibilities:Develop and implement quality assurance processes and procedures to ensure high-quality...

  • Quality Assurance Lead 2nd Shift

    2 days ago

    Fremont, California, United States Kraft Heinz Foods Company Full time

    Job DescriptionThe Kraft Heinz Company is seeking a Quality Assurance Lead to join our team at our sauces processing facility in Fremont, OH.This role is responsible for ensuring the quality of incoming materials and packaging, as well as leading and motivating a team of quality assurance specialists.The ideal candidate will have a strong attention to...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Sr. Quality Assurance Analyst Job DescriptionWe are seeking a highly skilled Sr. Quality Assurance Analyst to join our team at Info Way Solutions, LLC. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our software products.Key Responsibilities:Develop and implement test strategies, test metrics, and...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Sr. Quality Assurance Analyst Job DescriptionInfo Way Solutions is seeking a highly skilled Sr. Quality Assurance Analyst to join our team. As a key member of our quality assurance team, you will be responsible for developing and implementing software test strategies, plans, and processes to ensure the delivery of production-ready code.Key...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, United States Asahi Kasei 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...

  • Surveillance Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Surveillance Quality Assurance AnalystInfo Way Solutions is seeking a highly skilled Surveillance Quality Assurance Analyst to join our team.Responsibilities:Conduct daily reviews of data in ESSENCE-FL from state and regional perspectives.Provide consultation and training on the system to county health department and state level users.Perform...

  • Internal Audit Lead, Quality Assurance Specialist

    4 weeks ago

    Fremont, California, United States Neuralink Full time

    Job SummaryWe are seeking a highly skilled Internal Audit Lead, Quality Assurance Specialist to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.Key ResponsibilitiesConduct...

  • Quality Assurance Manager

    7 days ago

    Fremont, Ohio, United States Sanilac County Community Mental Health Authority Full time

    Job Title: Quality Assurance ManagerSanilac County Community Mental Health Authority is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest level of quality in our services and programs.Key Responsibilities:Develop and implement quality assurance processes...

  • Surveillance Quality Assurance Specialist

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job SummaryInfo Way Solutions is seeking a highly skilled Surveillance Quality Assurance Analyst to join our team. As a Surveillance Quality Assurance Analyst, you will be responsible for conducting daily reviews of data in ESSENCE-FL from state and regional perspectives, providing consultation and training on the system to county health department and state...

  • Quality Assurance Inspector

    1 week ago

    Fremont, California, United States Vishay Intertechnology Inc Full time

    Job Title: Quality Assurance InspectorVishay Intertechnology Inc is seeking a Quality Assurance Inspector to join our team in Fremont, CA.Job Summary:We are looking for a detail-oriented and organized Quality Assurance Inspector to perform in-process and final visual inspections of ceramic substrates using stereo zoom and high-power microscopes. The ideal...