Senior Specialist, Quality Assurance Technical Operations

Bristol Myers Squibb • Devens, MA

1d • Onsite

About The Position

This role is responsible for managing Quality Assurance aspects related to Quality laboratory operations. This includes quality oversight on laboratory-based initiatives such as technical transfers, equipment and method changes, investigations, and periodic trending and reporting. This role will liaise with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution, and act as a QA representative on associated projects related to Quality laboratory operations.

Requirements

• Knowledge of US and EU cGMP regulations and guidance.
• Past experience where one was required to work in a team-based environment with a diverse group of people.
• Excellent writing and oral communication skills are demonstrated.
• Demonstrated attention to detail, and the ability to perform well in a team-based environment are demonstrated.
• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertise.
• Excellent computer skills and proficiency with MS Office is demonstrated.
• Bachelor's degree in scientific discipline preferred or Associates degree with equivalent combination of education and work experience may be considered
• A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on quality operations desired

Nice To Haves

• Knowledge of biotech bulk and finished product manufacturing and associated analytical testing is highly desirable.
• Knowledge of electronic systems including any of the following: LIMS, Veeva, LES, Empower, Maximo desirable

Responsibilities

• Provides quality support through quality review and approval of investigations or change controls.
• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of laboratory operations including, incoming, in-process, release, and stability testing.
• Reviews and approves laboratory periodic trending and performance reports
• Liaises with internal partners (e.g., Quality control, analytical technology functions) in support of daily operations and conflict resolution
• Review and approval of validation/qualification/verification protocols and reports associated with new product or material entry.
• Ensures clear communication on issues and timely escalation as applicable
• Conducts quarterly walkthroughs of Quality Control laboratories
• Represent QA in cross functional meetings
• Provide training on QA owned procedures

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.
• Work-life benefits include: 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
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees