Qa Specialist Jobs

Summary:

We are seeking a highly motivated individual with to join our QA team to support antibody product development and manufacturing. This is an excellent opportunity for the right individual with a mindset of growth, collaboration, and continuous improvement. The QA Specialist I/II will support all aspects of QA operations to assure timely and high-quality clinical supply for our patients.

Responsibilities:

• Perform other duties as required.
• Support internal and external audits, health authority inspections, and partner audits, as necessary.
• Review technical protocols, reports, and methods, as appropriate.
• Support Quality initiatives for continuous improvement.
• Maintain QA logs and trackers related to batch disposition, stability, and CMO activities.
• Assist with creation and archival of QA documents in Veeva.
• Manage QA activities at contract service providers and alignment with Arcus procedures and industry best practices.
• Responsible for reviewing manufacturing batch records, QC release testing records, and quality events in support of batch disposition activities.

Qualifications:

• Bachelor’s degree in Life Sciences with 2+ years in a QA or a related CMC function (MSAT, Manufacturing or QC).
• Working knowledge of FDA, EMEA and other international regulatory expectations related to pharmaceuticals desired.

• Excellent written and verbal communication skills.
• Experience with biologics manufacturing, tech transfer, and validation in a pharmaceutical setting strongly preferred.
• Experience managing activities at CDMOs and CTLs a plus.
• Highly proficient with various Microsoft and other systems (Word, Outlook, Excel, PowerPoint, Visio, Veeva, Smartsheet, etc).
• Excellent organizational skills and ability to work on multiple projects/tasks with minimal supervision.

This role will be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $95,000 - $120,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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