QC Specialist

About the role

Responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. Provide assistance with the method transfer, documentation, deviations, investigations, and continuous improvement efforts.

Responsibilities

• Perform routine testing of in-process, final product and stability samples.
• May perform method transfer/validation and routine testing of in-process, final product, and stability samples.
• Perform data verification, data review, and review of GMP documentation for general and complex methods.
• Perform document revision.
• Identify opportunities for continuous improvement.
• Identify and initiate deviations, CAPAs and Laboratory Investigations.
• Train and mentor others on QC test methods, processes, and procedures.
• Perform other tasks as assigned.

Requirements

• Bachelor’s degree or equivalent required, preferably in science.
• 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in microbiological techniques (e.g., Gram Stain assays, sterility, environmental monitoring, endotoxin, growth promotion and aseptic technique).

Skills

• Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.
• Experience in technical writing preferred.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers about task status, roadblocks, and needs.
• Ability to work in a fast-paced environment, meet deadlines, and prioritize work.
• Knowledge of LIMS, ELN and laboratory data analysis.

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:
  • 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).
  • Paid Time Off (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 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 Year’s Day.

Pay

Bothell - WA - US: $38.30 - $46.41 per hour (full-time employee basis). Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Work Environment

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type is determined by the nature and responsibilities of the role:

• Site-essential roles: Require 100% of shifts onsite at your assigned facility.
• Site-by-design roles: May be eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
• Field-based and remote-by-design roles: The ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.