Cell Therapy Case Manager
Orca BioSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA at Bristol-Myers Squibb
Devens, Massachusetts, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Cell TherapyIndustries
Requirements
- Ability to work B2 shift (6pm–6am, rotating schedule including holidays and weekends, onsite in Devens, MA)
- Strong effective communication, critical thinking, and thirst for knowledge
- Experience in GxP compliance, Bristol-Myers Squibb policies, standards, procedures, and Global cGMP
- Ability to own quality decision making for unexpected events, deviation triage, and determination
- Capability to interact as Quality Representative with Manufacturing, Supply Chain, Quality Control, and supporting functions
- Participation in cross-functional triage meetings
- Ability to review or quality approve GxP records (e.g., procedures, batch records, deviations)
- Support deviation approval, alarm approval, and other Quality System Records
- Maintain compliance with assigned learning plan
Responsibilities
- Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations
- Identify departures from approved procedures and respond to complex issues independently; escalate critical issues to management
- Perform and document operational verification per approved procedures
- Develop, review, and/or approve temporary and non-routine procedures for event response
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
- Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans
- Own actions for departmental programs and propose improvements to programs
- Communicate and resolve discrepancies independently and escalate as required
- Author, review, and approve procedural documents
- Provide guidance and training for QA personnel; may own training curriculum and content
- Independently assess discrepancies for entry into quality system and approve records as applicable
- Lead meetings and represent function at cross-functional meetings
- Share data/knowledge within and across team; build and maintain strong relationships with partner functions
Skills
GxP
cGMP
Quality Assurance
Shop Floor
Cell Therapy
Manufacturing
Quality Control
Supply Chain
Warehouse Operations
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees