Hopewell, USA
3 days ago
Senior Site Quality Systems Specialist

BeiGene 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 will provide support for the IT Laboratory applications that enable the BeiGene Hopewell US Site Quality functions. This individual will partner with SMEs to provide solutions that support day to day business operations and improve ways of working. This individual will support projects and systems across the site.

This role will work independently with some supervision and provide technical direction, and support in the areas of Quality Control laboratory systems. This is an onsite role based in the Hopewell Site, NJ.

This individual will have experience in GMP change control, CAPA and investigations to support day to day operations; experience in software troubleshooting and working knowledge of data integrity principles.

Essential Functions of the job:

Strong communication and customer service delivery.Build strong relationships with the end user community.Author and support SOPs, WIs, and supporting validation documentation.Support of various lab instrument applications.Hands-on experience with Laboratory information management systems (LIMS), Waters Empower CDS (Chromatography Data System), Mettler Toledo LabX, SoftMax Pro, Environmental Monitoring systems, and Quality Management systems.Support the configuration, administration, and operational maintenance activities for site quality systems.Requires working in an industrial manufacturing environment including gowning.Support operations and ensure compliance with regulatory, corporate and site requirements.Support the triage of tickets to ensure lab operations is seamless.Experience working with end users to build best practices into the supported areas.

Qualifications: 

Bachelor’s degree with a scientific / engineering / Information technology background.Minimum 4 years of relevant work experience in building, configuring, and supporting Quality Control systems.Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV).Previous experience in a GMP manufacturing or operations environment.Experience with at least one of the following platforms: Waters Empower CDS, SoftMax Pro, MT LabX, Thermo Fisher LIMS, Environmental Monitoring.Experience authoring standard operating procedures.Experience in providing support for small to medium-sized projects and outside vendors.Effective written and verbal communications skills.    

Travel: 

Domestic and international travel less than 10%

BeiGene Global Competencies

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

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $114,100.00 - $149,100.00 annually

BeiGene 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 BeiGene 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 and we value diversity. BeiGene 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.

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