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.
This position is based in Hopewell, NJ. Supports QA Validation activities, ensuring the successful day to day operations by supporting validation documentation reviews, investigations, area walkthroughs, project activities and related Quality support activities. Works to support QA Key Performance Indicators (KPIs) such as Validation review/approval completion per schedule, SOP mandated cycle times, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs need to support the business.
Gain working knowledge of QA support of Capital Projects
Ensure all activities are performed in accordance with GMPs, SOPs and Health and Safety policies.
Observes qualification activities in drug substance, drug product, and quality control areas.
Redline procedures and GMP documentation for future revision and process improvement initiatives
Reviews GMP documentation (SAT, IQ, OQ, PQ, spec documents) for compliance with site procedures.
Supports Quality Assurance activities to ensure compliance with FDA/EU regulations.
Supports the writing and/or revising of SOPs, ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications.
Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and corrective action.
Ensuring that the Quality department meets or improves key performance indicators (KPIs).
Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood.
Core Competencies, Knowledge, and Skill Requirements
Scientific degree in progress (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline)
Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
Preferred experience working with an ERP system, such as SAP, and eQMS systems such as TrackWise or Veeva.
Ability to collaborate with project teams
Credible and confident communicator (written and verbal).
Customer focused, Strong analytical and problem-solving ability.
Hands-on approach, with a ‘can do’ attitude.
Ability to prioritize, demonstrating good time management skills.
Good 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.
Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)
Understanding of AI Tools
Significant Contacts
Interacts with primarily with peer levels of BeOne employees
Computer Skills:
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
Ability to work on a computer for extended periods of time
Working knowledge of AI Tools
Other Qualifications:
Must be able to work in the US without corporate sponsorship.
Pay Rate: Bachelors $27.00/Hour
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.
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 hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.