Senior Specialist, QA Investigations
Bristol Myers Squibb
Summary
The Senior Specialist, QA Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Summit Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.
Job description
Duties/Responsibilities
- Review and approve investigations/CAPAs/effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
- Review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
- Ensure the corrective/preventive actions and Effectiveness Check plans are robust and adequately addresses the root cause.
- May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
- Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
- Support internal and external inspections as required.
- Maintain compliance with assigned learning plan.
- Support development and delivery of training content to cross functional teams.
- Lead meetings and represent function at cross functional meetings.
- Share data/knowledge within and across team.
- Build & maintain strong relationships with partner functions.
Qualifications
Specific Knowledge, Skills, Abilities
- Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
- Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
- Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA.
- Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
- Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
- Ability to work in a fast-paced team environment and changing priorities.
- Detail oriented and task focused with ability to meet deadlines and support work prioritization.
- Able to work across functional groups and teams to ensure requirements are met.
- Self-motivated and contribute to a positive team environment.
- Confident in making decisions for Minor issues and able to recognize Quality issues and solve problems.
- Curious and ability to think critically to create innovative solutions.
Education/Experience/Licenses/Certifications
- Bachelor's degree in STEM field preferred.
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered.
- 4+ years of experience in a regulated industry with 1+ year deviation experience.
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
- Demonstrated experience with electronic system and databases.
- Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
Requirements
- 4+ years of experience in a regulated industry
- 1+ year deviation experience
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred
- Demonstrated experience with electronic system and databases
- Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
- Ability to research, understand, interpret and apply internal policies and regulatory guidelines
- Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications
- Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA
- Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles
- Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
- Ability to work in a fast-paced team environment and changing priorities
- Detail oriented and task focused with ability to meet deadlines and support work prioritization
- Able to work across functional groups and teams to ensure requirements are met
- Self-motivated and contribute to a positive team environment
- Confident in making decisions for Minor issues and able to recognize Quality issues and solve problems
- Curious and ability to think critically to create innovative solutions
Benefits
- Wellbeing support
- Retirement benefits
- Financial protection benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Flexible Time Off
- Paid company holidays
- Paid sick leave
- Paid volunteer days
- Summer hours flexibility
- Leaves of absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.