**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Fixe term contract : 1 year contract** **This role is part of QA Operations Release core team, responsible for end-to-end quality of product released on the market. The Senior Specialist, QA Operations reports to the Senior Manager, QA Operations. The Senior Specialist, QA Operations is responsible for overall batch release process, Raw Material review/approval, and Master Data Management review. This includes the review for disposition of commercial bulk product, semi-finished, and finished product batches manufactured at Celgene/BMS Boudry manufacturing site. The Senior Specialist may assist for risk assessments, as well as the support of health authorities' inspections and corporate audits. Special tasks can be assigned in crossfunctional projects/changes to support Boudry manufacturing site activities like new product introduction and launches. This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, as well as to contribute to process improvement in the scope of activity. All activities are to be done in a compliant, effective, and efficient manner in accordance with the timelines and agreements.** **Duties/Responsibilities** + Performs batch record review of commercial bulk product, semi-finished, and finished product batches manufactured, and prepare batch release documentation, using electronic MES platform. + Releases raw materials for production. + Populates, reviews, and approves creation/modification to master data in ERP/MES systems. + Supports the deviations and CAPA process within assigned areas of responsibility, including ownership of events/actions if applicable. + Supports the change control process, including ownership of records/actions if applicable. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility. + Reviews and approves as QA representative documents from partner departments and ensure documentation used for owned processes is up to date and in line with work in progress change controls. + Initiates or supports continuous process improvement initiatives, as assigned. + Contributes to risk assessments, e.g., related to quality issues or projects like new product introduction with the support of Senior Manager QA Operations. + Represents QA within department and cross-functional project teams according to assignments. + May provide training to other QA Release core team and Support team members. + May act as deputy of QA Release Core team members. • May be appointed as system SME (LIMS, MES, etc.) for QA Operations release processes, being responsible for the related activities. + Delegated tasks can be assigned to the Senior Specialist by the senior Manager as applicable, to support Global or local activities, e.g., Integration project, process improvement or other miscellaneous tasks. **Qualifications** + Minimum 3 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance + Bachelor's degree or equivalent degree/experience in a relevant discipline in science or related field. + Good understanding of cGMPs and regulatory requirements. + Good understanding of solid oral dosage form manufacturing is preferred. + Proven interpersonal, collaborative, and organizational skills. + Works independently on routine tasks, makes proposals and facilitates decisions when escalation is needed. + Ability to focus attention to details. + Good written & oral communication skills. + Investigational and problem-solving skills. + Knowledge of most common office software (Microsoft Office). If 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. **Uniquely Interesting Work, Life-changing Careers** With 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 an inclusive culture, promoting diversity 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 Protocol** BMS has a diverse 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. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1589085 **Updated:** 2025-02-01 04:37:07.980 UTC **Location:** Boudry-CH Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.