The Senior Specialist for the QA Sterility Assurance group is an individual contributor responsible for areas of oversight and support of aspects of the site contamination control strategy, including New Product Introductions (NPI). The position will also be responsible for quality approvals, including Environmental Monitoring (EM) investigations. Will provide investigational support for contamination events, and for supporting contamination control risk assessments.
Requirements
- Quality oversight and support for programs such as cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns.
- Quality oversight, support, and approval of Environmental Monitoring Excursion Investigations, including support for CAPA creation and Quality endorsement forums (Investigation Review Board & CAPA Review Board).
- Quality oversight and support for contamination investigations/CAPAs/effectiveness checks associated with, but not limited to environmental monitoring excursions, aseptic personnel qualification, aseptic operations, classified areas, utilities, and QC Microbiology testing related.
- Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.), as requested.
- Author impact assessments for low to moderate level site change controls, as requested.
- Participate in quality risk assessments associated with contamination control program, owned by sterility assurance or stakeholder departments. Assist with facilitation or serve as risk champion for department owned risk assessments.
- Support the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities. Support execution of site/team improvement goals and projects related to environmental and contamination control programs.
- Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve.
- Ability to collaborate with cross-functional team members on projects related to contamination control programs. Build and maintain strong relationships with partner departments.
- Lead meetings and represent department at cross-functional meetings sharing data and knowledge across team.
- Support New Product Introductions, environmental validations (Cleanroom Certifications, Environmental Performance Qualification, Aseptic Processing Simulations, and Airflow Visualization Studies), as needed.
- Participation in Aseptic Observer Program in manufacturing areas to ensure compliance with aseptic and cleanroom behaviors, gowning, cleaning, etc.
- Maintain compliance with assigned learning plan.
- Support internal inspections as required.
- 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
- 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
- Annual Global Shutdown between Christmas and New Years Day
