Berkeley Biologics was founded in 2023 and we are a multi-service tissue bank committed to honoring the gift of donation by providing high-quality allograft implants. Our comprehensive portfolio of products and solutions spans multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Wound Care.

The Quality Assurance Associate will perform donor and production record review efforts for all products.  They will ensure all records are in compliance with appropriate systems, policies and procedures and perform final disposition of tissue products.  This position will partner with operations to ensure compliance with applicable regulations and accomplish company goals of restoring health and mobility to the greatest number of patients possible. 

This position is onsite in our Richmond, CA facility and reports to the Director of Quality Assurance and Regulatory.

Responsibilities: 

• Perform record review of all production-related records to ensure compliance with applicable standard operating procedures, Current Good Tissue Practice (cGTP) and AATB Standards.
• Perform records review for final product disposition. 
• Maintain Quality records per standard operating procedures.
• Investigation of any non-conforming events identified during record review, CAPA investigations and complaint investigations, and associated containment and release actions.
• Perform Quality Control inspection of in-process and final product as needed.
• Coordinate with production for the collection of all samples to be sent for off-site laboratory evaluation, as needed. 

Experience and Skills:

• Bachelor’s degree in a life science field preferred.
• Minimum 2 years of direct experience in the field.
• Experience in a FDA-regulated environment, with knowledge of Human Cells, Tissues, and Cellular and Tissue-Based Products preferred. 
• Proficiency in Microsoft Outlook & Excel, and data entry skills.
• Excellent organizational skills, with the ability to handle multiple priorities and deadlines.
• Possess strong written, verbal and interpersonal communication skills.
• Available and adaptable to working fluctuating schedules, including weeknights, weekends, holidays and overtime as required.

Berkeley Biologics is an equal opportunity employer and does not discriminate on the basis of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We are proud to be an equal opportunity workplace.

The base pay range for this position is $28 - $34/hr depending on experience. 

Berkeley Biologics offers a competitive Benefits package:

•    Medical, dental, and vision insurance for employee and family

•    Life and disability Insurance

•    401(k) Retirement Plan with employer matching

•    Flexible Spending Accounts

•    Access to mental health platforms

•    Optional coverages employee can purchase for pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection

•    Generous Paid Time Off

•    8 Paid Holidays

•    A supportive, inclusive atmosphere on a team that values your contributions.  Our people thrive by being themselves and are inspired to do their best work every day.

 

Berkeley Biologics will only consider local candidates who can work on-site in our Richmond, CA facility and are authorized to work without the need for employer sponsorship.