Quality Assurance Specialist

Working At Bristol Myers Squibb

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.

Education and Qualifications

• Bachelor's degree preferred
• 4 years of relevant work experience required, preferably in quality assurance/quality control
• An equivalent combination of education, experience and training may substitute

Knowledge and Skills

• Basic knowledge of cGMP (FDA CFRs, EU Annex, etc), Occupational Safety and Health Administration (OSHA), United States Pharmacopeia (USP) and European Pharmacopoeia (EP)
• Basic to Intermediate knowledge of Quality Systems:
  Deviations, Change Management, Product Quality Complaints
• Basic to Intermediate knowledge of Validation Program
• Basic to Intermediate knowledge of Risk Management
• Ability to multi-task and be flexible
• Strong teamwork skills
• Ability to complete routine tasks with moderate direction; consults management for advice on complex issues, confident in making decisions for minor issues
• Ability to directly contribute to the team performance and team results
• Ability to follow established procedures and performs work as assigned
• Ability to follow directions and communicate effectively with peers, team, and management
• Ability to leverage internal relationships within function to achieve objectives
• Able to recognize conflict and notify management
• Basic writing skills, able to follow technical reports

Key Responsibilities

Compliance

• Provides sound quality guidance to all departments and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Bristol Myers Squibb (BMS) products and materials
• Adopts and constantly utilizes Quality Risk Management principles to make sound quality decisions
• Ensures the site meets all regulatory standards and consistently produces GMP compliant product

Customer Service

• Provides efficient and effective customer support to the other departments at the site
• Works with Plant Operations to ensure compliance with and understanding of cGMPs, standard operating procedures (SOPs), and policies
• Supports other departments by reviewing and approving change controls, document change controls, investigations, validation documents, and corrective actions preventive actions (CAPAs) in a timely manner
• Assist with Product Quality Complaint (PQC) investigations
• Assist and may act at QA representative for site projects and initiatives
• Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner

QA Knowledge and Skills

• Possesses proficiency in reviewing and approving deviations, change controls, validation documentation, and other GMP documents
• Possesses a strong, detailed knowledge of site's manufacturing processes and procedures
• Proposes solutions for issues and works with management to resolve
• Actively contributes towards team goals
• Performs all other tasks as assigned

Working Conditions

• Work is generally performed seated, but may require standing and walking for up to 20% of the time
• Work requires completion of an eye examination to demonstrate 20/20 correctable vision
• Work occasionally requires uniform/personal protective equipment (PPE) to work in a manufacturing, warehouse, or laboratory environment

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

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated…