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Specialist, QA Document Control Operations

Company: Celgene
Location: Newark
Posted on: May 16, 2022

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.PURPOSE AND SCOPE OF POSITION: The Specialist is responsible for day-to-day QA Document Control operations at the Summit, NJ site, in accordance with Cell Therapy Operations (CTO) policies, standards, procedures and global cGMPs. The position executes Document Control activities including but not limited to: Records Management System (RMS) administration; printing, issuance, and maintenance of controlled documents (including analytical forms, logbooks, drug product batch records and clinical drug product labeling); Support to other functional areas of operations; and review and approval of site specific procedures. This position reports to the Manager of S12 Documentation Control. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: ---Must have experience with cGMP manufacturing, Quality, and compliance.---Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.---Comfortable providing input within the department and across the organization.---Able to write and review technical reports with clarity and brevity.---Provides guidance to other employees in technical writing skills.---Good understanding of software development Life Cycle (SDLC) and electronic document management systems.---Good understanding of records management systems and retention policies.---Completes routine tasks with little or no supervision.---Requires moderate direction to complete more complex tasks.---Recognizes risk for assigned project/processes and mitigates accordingly.---Propose solutions for complex issues and work with management to resolve.---Understands the basics of continuous improvement and improves efficiency and productivity within the group or project.---Comfortable providing training/guidance to system users as needed, and in instructor-led settings.---Able to recognize conflict and notify management with proposed recommendations for resolution.---Able to prepare written communications and communicate problems to management with clarity and accuracy.---Able to produce data reports with precision.---Must be time organized and self-directed.---Able to support internal and health authority inspections of facility.EDUCATION AND EXPERIENCE:---HS diploma or equivalent required. College or university degree preferred.---3+ years of related Quality experience in the pharmaceutical or related industry.---An equivalent combination of education and experience may substitute.DUTIES AND RESPONSIBILITIES: ---Serve as a documentation system SME and provide guidance to system users as needed.---Serve as a Document Control Reviewer/Approver on documentation managed through the electronic GMP/GDP documentation management system.---Prints/Issues Master Batch Records and Batch Record Related documentation.---Prepares/Issues logbook and Quality Control Form requests.---Assists with maintenance and administration of procedures related to job function.---Systematizes and streamlines document workflows.---Maintains training material for applicable document management systems.---Provides end-user training on electronic document management systems.---Works independently and has a direct impact on documents that are subject to regulatory authority inspection.---Compiles applicable process metrics, identifies trends and escalates accordingly.---Coordinates activities and projects with other functions, such as GMP Training.---Ensures that documentation complies with established documentation system process/requirements.---Provides support during internal and health authority inspections of facility.---Monitors the periodic review process for documents.---Communicates effectively with all cross functional and regional stakeholders on matters related to documentation systems.---Distributes official documents to internal and external customers as needed.---Works with team to implement records management policies and schedules for the electronic and physical records as needed.---Carries out plans and actions in the documentation system to support acquisitions, new product launches, product in-license operations, new market and trading partner opportunities, and other quality management activities as assigned.---Supports Quality Systems harmonization efforts.---Performs other tasks as assigned.WORKING CONDITIONS (US Only): Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Light to moderate lifting may be required, up to 25 lbs. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Celgene, Newark , Specialist, QA Document Control Operations, Other , Newark, New Jersey

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