BeOne Medicines · 7 hours ago
Data Reviewer, QC, US Site (Hopewell, NJ)
Hopewell, NJ
Full-time
Onsite
Mid Level
$91K/yr - $126K/yr
4+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking experienced professionals for their team. The Data Reviewer, QC role involves reviewing QC data and test records to ensure compliance with Good Manufacturing Practices (GMP) under FDA/EU regulations, supporting investigations related to quality control results, and assisting in technical documentation.
Pharmaceuticals
Responsibilities
Review and validate QC data and test records
Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results
Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory
Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards, and BeOne Medicines protocols
Interacts with all levels of BeOne employees
Undertake other duties as required
Qualification
Required
Bachelor's Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline
Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required
Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc
Strong working knowledge with USP/EP and cGMP/EU GMP
Technical writing experience
Familiar with instrument and equipment validation
Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level
Credible and confident communicator (written and verbal) at all levels
Strong analytical and problem-solving ability
Hands-on approach, with a ‘can do' attitude
Ability to prioritize, demonstrating good time management skills
Excellent attention to detail, with the ability to work accurately in a busy and demanding environment
Self-motivated, with the ability to work proactively using own initiative
Committed to learning and development
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Must be willing to travel approximately 10%
Ability to work on a computer for extended periods of time
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase