QA Contractor I

BeOne Medicines; San Carlos (CA); On-site; USD 37,000 - 49,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

BeOne Medicines is seeking a temporary QA Manager to oversee quality events, labeling reviews, and vendor performance within its Contingent Workforce Program in partnership with Magnit Global. You will work with CMOs under GMP constraints and ensure deviation, complaint, and change-control processes meet BeOne SOPs.

The role requires 3+ years in QA management, familiarity with cGMP, GDP, and GCP, and a Bachelor's in Pharmaceutics or Chemistry.

Qualifications

• 3+ years in quality assurance management with CMOs.
• Familiarity with cGMP, GDP, and GCP is a plus.
• Ability to analyze and resolve issues independently.

Responsibilities

• Quality events management such as deviation, complaint, and change control to ensure events handling meet GMP/QAA requirements.
• Oversee labeling/relabeling at CMOs and approve labeling batch records.
• Comparator Product Release prior to secondary packaging operations.
• Review and approve Supply Chain Table Part I & II, including QA input for Change Control.
• Clinical Label Compliance Review and Approval.
• Vendor performance monitoring and periodic assessment.
• Review/revise QAA between BeOne and external packaging sites.

Skills

Quality assurance management

CMO collaboration

GMP knowledge

Problem solving

Education

Bachelor’s degree in Pharmaceutics or Chemistry

Job description

Temporary work opportunities align well with professionals seeking career flexibility and non-traditional ways of working, while being driven to deliver exceptional results in high-profile environments. Magnit Direct Source is a service offered by Magnit Global that connects top talent directly to industry-leading clients with flexible temporary assignments across a variety of impactful projects.

BeOne Medicines is creating the world’s next generation cancer treatments. As a global oncology company focused on uniting against cancer, BeOne Medicines brings together passionate professionals dedicated to making a difference for patients worldwide.

This opportunity is part of BeOne’s Contingent Workforce Program in partnership with Magnit Global. As a temporary contractor supporting BeOne Medicines, you will be employed by our contingent talent partner, Magnit Global, who manages BeOne’s contingent and temporary workforce.

Magnit Global is a leading workforce solutions and technology company specializing in contingent workforce management. Magnit partners with organizations across industries including healthcare, pharmaceuticals, research and development, consumer electronics and more. Magnit offers a comprehensive benefits package, including medical, dental, vision, and 401(k).

Magnit is a leading, global professional services and technology company and a certified "Great Place to Work." We have been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more. Magnit offers benefits including medical, dental, vision, and 401(k).

General Description

• Quality events management such as deviation, complaint, and change control to ensure all events handling meet requirements in GMP regulations/QAA and BeOne SOP.
• Oversee product labeling/relabelling activities at CMOs. Review and approve labeling batch records, ensure the pre-defined leading time and be able to support urgent needs when necessary.
• Comparator Product Release prior to secondary packaging operations.
• Supply Chain Table PartⅠ&Ⅱ Review and Approval, including Quality assessment and input for the associated Change Control.
• Clinical Label Compliance Review and Approval.
• Vendor performance monitoring and periodic assessment.
• Review/revise QAA between BeOne and external packaging sites and depots.

Essential Functions Of The Job

• Experience more than 3 years in quality assurance management, working with CMOs and expertise in the pharmaceutical industry is a plus.
• Familiarity with cGMP regulations, GDP, and GCP is a plus.
• Ability to analyze and resolve issues independently.

Education/Experience Required

• Bachelor’s degree or above in Pharmaceutics/Chemistry or related degree.

Preferred/Nice To Have

• Experience in quality assurance management and working with CMOs.
• Knowledge of cGMP regulations, GDP, and GCP.

This is the pay range that Magnit reasonably expects to pay for this position: $26.79/hour - $35.71/hour

Benefits: Medical, Dental, Vision, 401K