Senior Specialist, Quality Assurance
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Job Location:
Hopewell, NJ - USA
Yearly Salary:
$ 91400 - 126400
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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:
This position is based in Hopewell NJ.Supports QA manufacturing activitieswithstrongfocusinQCMicrobiology.Support for Biochemistry and the analytical chemistry department may also be required.Candidate will ensure the successfulday-to-daymanagement of reviewing and approving GMP paperwork including logbooks analytical raw data Environmental Monitoring reports and other ancillary documentation that support GMP Manufacturing.Candidate will also provide QA oversight of OOS anddeviationspertaining tosamples from Production EnvironmentalMonitoringand WFIsystems.Willbe responsibleforleadingGEMBA walkson a routine basis to ensure day-to-day complianceand toensure the laboratory andfacility are always inspection ready.
Works to support QAobjectiveswhilst adhering to regulatory compliance and achieving business success. Creates and/orreviewsSOPs needed to support the business.Conductsinternal GMPinspectionsandwill supportHealth Authority audits.
Essential Functions of theJob:
Implementing andmonitoringall Quality Assurance activities inQC Microbiologicallaboratories and facility/utility space to ensure compliance with FDA/EU regulations covering cGMP for commercial medicinal products and clinical material for human use.
Ensuring the QA Compliance of departmental SOPs (writing & revising) ensuring regulatory compliance in conjunction with being fit for purpose operationally and commercially.
Knowledgeable incGMPs: 21 CFR Partsand 600 EU Annex 1.
Demonstratedexpertisewith ERP systemsand lab dataacquisition systemssuch as: EmpowerMaximo Veeva LIMS MODA and SAP.
Ensuring all activities are performedin accordance withGMPsSOPsand Health andSafety policies.
Awareness of USP/EP ICH GuidelinesAnnex1 andQCmethodologyupdates to ensure compliance with current testing and specifications.
Ensuringappropriate escalationand follow up for non-conformities within Laboratories and Utility areas and issuing deviations whenappropriate.
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 QA Management for which training and/or an explanation has been provided and understood.
Perform other duties as assigned
Supervisory Responsibilities:
None
Computer Skills:
Strong PC literacy; MS Office skills (Outlook Word Excel PowerPoint MS Project).
Required Education/Experience:
Abachelorsdegree in: Biology Chemistry Biochemistry or engineering or other life science degree is required.Advancedegree ispreferred but not.
4 years of QA experience is. Strong preference for significant prior QC experience.
Experience with writing/reviewing deviations Environmental Monitoring data/trends aseptic technique technical writingclean roomgowning
Must have worked previously in the Biotechnology area of pharmaceuticals.
Travel:10%Travel may be.
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
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 .
Required Experience:
Senior IC
