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

    BeOne Medicines (Pennington, NJ)


    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-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.