Senior Specialist, Quality Assurance job opportunity at BeOne Medicines.

Home Jobs In United States Of America Tag: Quality Assurance Senior Specialist, Quality Assurance position at BeOne Medicines


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BeOne Medicines Senior Specialist, Quality Assurance
Experience: 4-years
Pattern: full-time
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Quality Assurance

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degreeMBA
loacation Hopewell, United States Of America
loacation Hopewell....United States Of America

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 activities   with   strong   focus   in   QC   Microbiology .   Support for Biochemistry and the analytical chemistry department may also be required .     Candidate will ensure the successful   day-to-day   management 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 and   deviations   pertaining to   samples from Production, Environmental   Monitoring   and WFI   systems .    Will   be responsible   for   leading   GEMBA walks   on a routine basis to ensure day-to-day compliance   and to   ensure the laboratory and   facility are always inspection ready .    Works to support QA   objectives   whilst adhering to regulatory compliance and achieving business success. Creates and/or   reviews   SOPs needed to support the business.   Conducts   internal GMP   inspections   and   will support   Health Authority audits.   Essential Functions of the   J ob:    Implementing and   monitoring   all Quality Assurance activities in   QC Microbiological   laboratories 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 in   cGMPs : 21 CFR Parts 11, 210, 211, and 600 , EU Annex 1 .   Demonstrated   expertise   with ERP systems   and lab data   acquisition systems   such as : Empower,   Maximo, Veeva, LIMS, MODA, and SAP.   Ensuring all activities are performed   in accordance with   GMPs,   SOPs   and Health and   Safety policies.   Awareness of USP/EP, ICH Guidelines,   Annex   1, and   QC   methodology   updates to ensure compliance with current testing and specifications.   Ensuring   appropriate escalation   and follow up for non-conformities within Laboratories and Utility areas and issuing deviations when   appropriate .   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 o ther duties as assigned   Supervisory Responsibilities:      Non e   Computer Skills:   Strong PC literacy   required ; MS Office skills (Outlook, Word, Excel, PowerPoint , MS Project ).   Required Education/Experience: A   bachelor’s   degree in: Biology, Chemistry, Biochemistry, or engineering , or other life science degree is required .    Advance   degree is   preferred but not   required .    4+ years of QA experi ence is   required . Strong preference for significant prior QC experience.    Experience with writing/reviewing deviations, Environmental Monitoring data /trends , asept ic technique, technical writing,   clean room   gowning     Must have worked previously in the Biotechnology area of pharmaceuticals.    Travel:   10%   Travel may be   required .   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: $91,400.00 - $126,400.00 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 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 .

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