Manager, QA Lot Disposition
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Bachelor’s degree in a life or physical science discipline.
- Minimum of 7 years working in a Quality role within a commercial or clinical biopharmaceutical, cellular therapy, or gene therapy organization.
Knowledge, Skills, and Abilities
- Knowledge of cGMP regulations and FDA guidance’s applicable to biologics and cell therapy.
- Detail oriented, with strong good documentation practices expertise.
- Direct experience with lot disposition supporting the manufacturing, testing, disposition, and distribution of CGMP products.
- Excellent communication, trouble shooting, and problem-solving skills.
- Strong team player that can also work independently to achieve objectives.
DUTIES AND RESPONSIBILITIES:
- Conduct routine lot disposition activities for finished drug products by ensuring all relevant documentation associated with a lot are accounted for, completed and approved under cGMP standards.
- Review and approve the QC documentation related to each lot (Certificate of Analysis and QC testing data, including EM and analytical data).
- Perform the review of lot genealogy for all raw materials and components used in each lot to ensure they are approved and released using the electronic system (Manufacturing Execution System).
- Conduct the lot disposition process and ensure the Dosage assignment is reviewed and approved by the appropriate individuals.
- Collaborate with stakeholders and management and communicate lot disposition status; monitor progress and issue status reports.
- Assemble and review Quality system documents such as, deviations, batch production records, test methods, specifications, and controlled forms associated with each lot for disposition.
- Create and revise relevant Standard Operating Procedures (SOP), Work Instructions (WI), Forms, and Reference Documents as needed.
- Support internal and external audit activities, batch record reviews, change controls, and other QA department needs as identified by management.
WORKING CONDITIONS (US Only):
- Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach
- Requirement to work in an office environment, potentially requiring ergonomic considerations
- Requirement to work in a conference room / meeting environment for moderate periods of time
- Occasional periods in labs or production area, requiring some level of gowning
- Occasional domestic or international travel
- Light to moderate lifting
- Regular, predictable attendance is required, plus occasional overtime, as business demands dictate
- Shift work and routine weekend coverage is required.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.