Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking
Ability to understand, follow, and apply internal policies, procedures, and quality principles
Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA
Availability for 6pm–6am rotating shifts, including holidays and weekends, onsite in Devens, MA

Responsibilities

Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
Interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy
Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members
Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures
Observe manufacturing operations and identify departures from procedures, cleanroom behaviors, and aseptic techniques
Provide quality oversight for pre-planned return to service plans
Perform area walkthroughs to identify quality issues, propose remediations, and support implementation plans with area owners
Identify and propose improvements to programs, procedures, and practices
Review manufacturing batch records or QC testing records to ensure compliance with approved procedures
Review and provide feedback on documents such as forms, logbooks, and procedures
Maintain compliance with assigned learning plan and provide integration support of newer team members
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback
Participate in quality and shift meetings
Build and maintain relationships with core partner functions and seek collaborative solutions
Share data/knowledge within team by acting as a champion for quality-culture

Skills

Key technologies and capabilities for this role

cGMPQuality AssuranceShop Floor OversightManufacturingQuality ControlWarehouse OperationsCell TherapyComplianceEvent Triage

Questions & Answers

Common questions about this position

What shifts are available for this QA Shop Floor Specialist role?

Shifts available are 6pm – 6am with rotating scheduling including holidays and weekends, and the role is onsite.

What is the salary range for this position?

This information is not specified in the job description.

What key skills are needed for the QA Shop Floor Specialist role?

Key skills include providing quality oversight on the shop floor, interpreting and triaging issues, performing operational verifications in MES, observing manufacturing for compliance with procedures and aseptic techniques, and reviewing batch records.

What is the company culture like at Bristol Myers Squibb?

The culture is described as challenging, meaningful, and life-changing, with opportunities to grow alongside high-achieving teams, emphasizing balance, flexibility, and work that transforms patients' lives.

What makes a strong candidate for this QA Shop Floor role?

Strong candidates can independently identify and respond to departures from procedures, escalate complex issues, communicate clearly and accurately, perform area walkthroughs to propose remediations, and suggest improvements to programs and practices.

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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