Position Summary: 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.
Duties/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, CAPA's and Laboratory Investigation.
- Train and mentor others on QC test methods, processes, and procedures.
- Perform other tasks as assigned.
Qualifications - Education and Experience
- 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).
Knowledge, Skills, and Abilities
- 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
Compensation Overview:Bothell - WA - US: $38.30 - $46.41per hour
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) 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.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science™ " , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolBMS 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 that you are assigned is determined by the nature and responsibilities of your 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. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For 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.