Scientist, Quality Control (QC) Systems

Bristol Myers Squibb • Devens, MA

1d • $107,100 - $129,780 • Onsite

About The Position

The Scientist, QC Systems at the Cell Therapy Facility (CTF) is responsible for the development, configuration, and management of QC electronic systems and applications supporting QC operations. This role acts as a subject matter expert in providing electronic systems operational support and troubleshooting to QC end users and will interface with both internal and external functions to implement electronic system improvements to optimize business processes and improve efficiency.

Requirements

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced technical, problem-solving skills and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Demonstrated technical writing skills.
• Mentoring, coaching, influencing, negotiating and personnel interaction skills.
• Knowledge of analytical and microbiological test methods and environmental monitoring programs.
• Bachelor’s degree or equivalent required, preferably in science or related engineering field.
• 6+ years of relevant work experience in LIMS, ELN and laboratory software systems (e.g., Smart-QC), preferably in a regulated environment.
• An equivalent combination of education and experience may be considered.
• Demonstrated experience with validation and/or maintenance of laboratory electronic software systems.
• Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height.
• Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
• Ability to independently don, doff, and wear required personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
• Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
• Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability to use step stools while reaching and handling materials.
• Ability to work in a Biosafety Level 2 (BSL-2) environment.
• The laboratory employee is responsible for performing work safely in accordance with EHSS procedures. This includes identifying and controlling risks, proper use of personal protective equipment (PPE), safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and active participation in training and safety programs.

Responsibilities

• Create, deploy, review and sustain electronic systems Master Data. Perform data verification, system integration (Smart-QC, LIMS, ERP, and MES) for electronic systems.
• Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
• Provide electronic systems operational support and troubleshooting to end user.
• Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop business case.
• Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives.
• Anticipate and perform troubleshooting and problem solving independently.
• Train and mentor others on electronic systems use and operation.
• Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution.
• Facilitate design, testing and subsequent deployment of solutions.
• Perform other tasks as assigned.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Paid Time Off
• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior