Senior Specialist, QA Operations

Job title:

Senior Specialist, QA Operations

Company

Bristol-Myers Squibb

Job description

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: .QA Operations team is committed to actively support Celgene/BMS Boudry manufacturing site and other departments to ensure cGMP compliant production, testing and release of product on the Boudry manufacturing site.You will be responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the Boudry manufacturing site.Also, you will be responsible for the assigned processes and activities within QA Operations and will mainly act as member of the Quality oversight for end-to-end process at BMS Boudry Manufacturing site. The activities include responsibility for execution of the main following processes: deviation and CAPA, change control handling, QA oversight of validation and qualification activities.Additional tasks are risk assessments, as well as the support of health authorities inspections and corporate audits.The Senior Specialist, QA Operations can be assigned special tasks in cross-functional projects 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 quality process and cGMP compliance related issues, as well as to contribute to process improvement in his/her scope of activity.In this role, you will also support quality on the floor for manufacturing, packaging, QC, and warehousing activities in collaboration with the other members of the team of quality operation. The team works closely with the QA operation release team to achieve the site objective and release the products on time. As part of the quality on the floor organization, a capability to solve issues on call is required.The Senior Specialist QA is also a key member of the site governance trough the tier meetings processes. He/ She is responsible to address the quality topics, take appropriate decisions at the right level, and bring any escalation to management, if necessary, in a clear and factual manner. This position is key to facilitate problems resolution at the right level.The Senior Specialist, QA Operation can work autonomously carry escalation and follow all the topics from start to end in a proactive manner and behavior.Duties/Responsibilities

• Support the deviation process. Ensure (and lead if necessary) that the initial quality assessment is completed in a timely manner according to requirements, support investigators , assess the criticality, review and approve the deviations, related CAPA and effectiveness checks.
• Support the CAPA process by performing QA impact assessment, approving the CAPA plan, and the completed actions. Ensure review and approval of effectiveness check.
• Support the change control process. Perform action plan evaluation and coordinate change control progress within assigned areas of responsibility, review and approve Change Control.
• Review and approve as QA representative Qualification and Validation activities documents (protocols, reports…).
• Contribute to risk assessments, e.g. related to quality issues or projects like new product introduction.
• Represent QA within department and cross-functional project teams according to assignments.
• Act as backup for colleagues within QA Operations team.
• Contribute to documents revision. Can take the ownership of processes and document revision.
• Support health authorities and internal inspections in different roles (SME, coordinator, etc…)
• Participate to Quality KPI establishment and monitoring.
• Manage the product quality complaints process by performing triage activities, coordinating the complaint support, handling complaints and executing investigations within due dates as assigned.
• Will provide regulatory compliance support across the end-to-end product lifecycle for validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.

Qualifications

• BS or MSc in Science or related field.
• At least 5 years of experience in a pharmaceutical company or other related industry.
• Good understanding of cGMPs and FDA regulatory requirements.
• Good understanding of solid oral dosage form manufacturing processes is preferred.
• Proven interpersonal, collaborative and organizational skills. Ability to handle several tasks simultaneously.
• Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
• Ability to focus attention to details and analytical thinking

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 ProtocolBMS 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 . Visit 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:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Expected salary

Location

Boudry, Neuchâtel

Job date

Sat, 25 Jan 2025 08:28:27 GMT

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