Data Reviewer, QC, US Site (Hopewell, NJ)

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

Review QC data and test records in accordance with BeOne procedures to support GMP testing and release of materials, intermediates, and finished products under FDA/EU regulations and applicable international regulations. This role is essential for ensuring compliance with Good Manufacturing Practices (GMP) for the testing and release of materials, intermediates, and finished products, adhering to FDA/EU regulations and other applicable international standards.

Essential Functions of the job:

• 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.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

• Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).

• 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, 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

• Self-motivated, with the ability to work proactively using own initiative.

• Committed to learning and development.

Computer Skills:   

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:   

• Must be willing to travel approximately 10%.

• Ability to work on a computer for extended periods of time.

Driving Excellence

• Results-Oriented

  Analytical Thinking/Data Analysis

  Financial Excellence

  Communicates with Clarity

 

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $90,900.00 - $125,900.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or