Senior Specialist, Quality Assurance Shop Floor, Cell Therapy at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Ability to provide 24x7 Quality collaboration and oversight of site operations including Manufacturing, Quality Control laboratories, and Warehouse Operations
Knowledge of Bristol-Myers Squibb policies, standards, procedures, and Global cGMP
Skills in monitoring and tracking process performance related to key Shop Floor quality assurance tasks through data and analytics
Capability to own, review, or approve Floor Quality GxP records including procedures, CAPAs, change controls, impact assessments, documentation, or deviations
Ability to support deviation approval, alarm approval, other Quality System Records, or batch record review
Effective communication, critical thinking, and thirst for knowledge
Monday to Friday, Day shift schedule availability
Compliance with assigned learning plan
Ability to guide and train QA personnel
Capability to own training curriculum and content
Ability to present during audits

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
Participate in Gemba walks
Communicate and resolve discrepancies independently and escalate as required
Author, review, and approve procedural documents
Provide guidance and training for QA personnel
Independently assess discrepancies for entry into quality system and approve deviations as applicable
Serve as quality subject matter expert for risk assessments, change controls, etc
Lead meetings and represent function at cross-functional meetings
Share data/knowledge within and across team; build and maintain strong relationships with partner functions
Prioritize and assign tasks for the team
Periodically observe operations

Skills

cGMP

Quality Assurance

Shop Floor QA

CAPA

Change Control

Deviations

GxP

Data Analytics

Manufacturing Oversight

Impact Assessments

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

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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