Associate Quality Analyst I
About the Job
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY.
The Associate Quality Analyst I is responsible for supporting the site supplier quality and material disposition system.
- Prepares SQA documents supporting supplier qualification and certification to ensure material and supplier compliance throughout their lifecycle in accordance with directives and procedures.
- Participate in network teams to identify and resolve material compliance risks.
- Perform quality assessment for supplier change notifications, BMS change controls, excipient materials, material certification and annual reviews including audit status.
- Provide support as an investigational team member for supplier or material related non-conformance events. Responsibility includes completion of assigned action plan tasks.
- Create, revise and maintain Quality Agreements for suppliers of materials and services used by the site.
- Responsible for performing SAP, GDR, LIMS, Trackwise, DCA and other applicable system transactions relating to supplier qualification and certification activities.
- Author and revise procedures for supplier qualification and certification programs.
- Actively participate in and support inspection readiness activities.
- Contribute to site improvement programs for supplier and material qualification/certification to meet evolving regulatory guidelines and to streamline processes.
Specific Knowledge, Skills, Abilities, etc\:
- Knowledge and understanding of FDA, EU and ICH regulations and guidance including cGMPs,
- Experience and skillset to work in a regulated environment as well as the importance of following procedures, cGMPs and EHS is highly desirable.
- Previous experience in providing sound justification and explanation to representatives from health authorities / regulatory agencies is desirable.
- Knowledge of electronic systems including\: SAP, GDR, LIMS, TrackWise, DCA, and Microsoft Office Suite is highly desirable.
- Previous work responsibility, which required a high degree of attention to detail.
- Ability to work independently and make sound judgments in assuring compliance with regulations under tight timelines.
- Demonstrate excellent organizational skills and ability to effectively prioritize work.
- Effective interaction with all contacts and the ability to work in a team based environment and interact well with other employees at various levels.
- Must be flexible and capable of handling several high priority items simultaneously on an ongoing basis.
- Knowledge of lean manufacturing/operational excellence principles or ability to obtain this skillset through participation as a change agent for continuous improvement is desired.
- Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
- Minimum of 1-3 years direct biologics Manufacturing, Quality Assurance, or Quality Control experience
- Sitting, standing, walking
- Repetitive (Use of Arm, Hands, Wrists – computer work)
- Office space
- Inside Work
- Working Alone
- Working with/around others