Sr Specialist, Aseptic Observation Program - Bothell WA

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.Position SummaryThe Aseptic Observation Program (AOP) Sr. Specialist is responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing feedback on aseptic techniques, behaviors, and processes. The specialist serves as the manufacturing subject matter expert in aseptic behaviors and practices, collaborating with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives.Duties/Responsibilities Observe aseptic operations (e.g., filling, media preparation, gowning) to ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements. Document observations in real-time and areas for improvement. Provide immediate feedback and coaching to operators and managers regarding aseptic technique, gowning, and compliance. Perform staff Aseptic Processing and Gowning Qualifications. Participate in root cause analysis and investigations related to aseptic process deviations or contamination events. Performs document revisions as needed to improve instructions and training. Support the development and delivery of aseptic technique training programs. Collaborate with Quality Assurance, Manufacturing, and MSAT teams to implement corrective and preventive actions. Maintain detailed records and reports of observations, findings, and recommendations. Stay current with industry best practices, regulatory updates, and training related to aseptic processing. Assist in internal and external audits as a subject matter expert for aseptic operations. May support APS, CRC, and EMPQ activities through aseptic observations.Reporting RelationshipManager/Sr. ManagerAuto req ID471429BRMinimum Education RequiredHigh School/GEDJob_CategoryAnalystQualificationsAdditional Qualifications/ResponsibilitiesEducation/ExperienceBachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 4 years of relevant experience in biologic or cell therapy.Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1. Excellent observational, documentation, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Experience with training or coaching operators is a plus.Experience with ergonomics relating to aseptic techniques and aseptic behaviors.Experience with electronic quality management systems.Experience with cleaning and sanitization practices.Skills & Abilities Certification in aseptic processing or quality assurance. Experience with sterile injectable products. Experience with electronic quality systems. Knowledge of cGMPs. Cell therapy and aseptic processing experience is required. Ability to collaborate and influence cross-functional teams. Experience with leading change management is preferred.WORKING CONDITIONS (US Only) Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B). Must be able to stand for extended periods of time. Work in areas that may have strong magnets. Work in areas where handling human blood products (Biosafety Level 2) may be required. May work in areas with exposure to vapor phase liquid nitrogen. Must be able to gown in and be present in the Grade A/B environment for extended periods of time.ShiftsSun - Wed: 7am - 5:30pmSun - Wed: Noon - 10:30pmWed - Sat: 7am - 5:30pmWed - Sat: Noon - 10:30pmIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation OverviewBothell - WA - US: $96,832 - $117,338City*BothellState*WashingtonJob CodePharmaceutical PharmaceuticalAffiliate SponsorBristol Myers Sqibb BMSSalary Range>$100,000