QC Data Management Specialist

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a QC Data Management Specialiston a long term Contract basis. Location: Summit, NJ Rate type: W2 only POSITION:The Data Management Scientist is responsible for supporting data management related activities within the S12 Quality Control department in direct support of clinical and commercial CAR T manufacturing activities. This individual will focus on the timely and quality delivery of data review, storage in physical and electronic binders.This includes the ability to interface with cross functional groups, independently perform tasks, ensure completion of all testing documentation and filing in the patient binders and CoA issuance. Additionally, the QCDM Scientist will be responsible for continuous improvement of the data management processes, Right First Time initiatives, and streamlined disposition of CAR T drug products from the Summit West S12 Facility.REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Advanced Working experience in data management in a cGMP environment.Ability to keep accurate records, strong attention to details, follow instructions, and comply with company policies.Advanced ability to accurately and completely understand, follow, interpret and apply GlobalRegulatory and cGMP requirements.Advanced ability to communicate effectively with team members, department management and cross-functional peers.Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Good interpersonal skills are a must.Advanced technical writing skills.Advanced problem-solving ability/mentality, technically adept and logical.Ability to represent the interests of the S12 QC organization on cross-functional teams.Knowledge of data trending and tracking, including use of statistical analysis software a plus.Ability to set priorities, manage timelines and effectively react/manage changing priorities.Ability to work with management (global and site) and support corporate and departmental goals.Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.Ability to utilize electronic Quality systems.Education and Experience: Requires a bachelors degree in science, preferably in Biochemistry, Immunology, Molecular and Cellular Biology, Biology, Microbiology or related discipline.2-4 years of relevant work experience, preferably in a health authority regulated environment.Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).An equivalent combination of education and experience may substitute.DUTIES AND RESPONSIBILITIES:Generate patient binders both physical and electronic according to the manufacturing scheduleSupport Data review of QC Data as neededEnsure all required data are reported and reviewed by the QC operations teams according to the corresponding procedures and that these milestones are completed for on time disposition of CAR T drug products.Ensure binder completion (physical and electronic), CELabs review completion prior to CAR T drug product lot dispositionIssue, review and approve CoAs for CAR T drug product lots.Participate in data integrity and process mapping projects.Support CAPAs, NOE creation and investigations.Actively participate in strategic planning and coordination activities with QC scheduling and planning, QA Disposition and Global Supply Chain to ensure on time disposition of cellular drug product lots.Ensure that all interim dispositions assessments are completed for deviations impacting cellular drug product lots prior to their target site disposition dates.Be Single Point of Contact for QC DataInitiate change control documentation and assist other QC functional groups with change management documentation.Identify functional area SMEs to perform impact assessments as part of the change management process.Provide technical support for manufacturing investigations / CAPAs / change controls as needed.Support QC during audits and site inspections for QC compliance related inquiries.Handle complex issues and solve problems with minimal guidance.Serve as author or technical reviewer of departmental procedures as appropriate.Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.Continuously support QC, living the patients first mission and fostering a Right First Time mindset.Sincerely yours, Nitin Patel Senior Technical Recruiter TSR Consulting Services, Inc. 379 Thornall Street, 6th Floor, Edison, NJ 08837 Office: www.tsrconsulting.com