Associate II, QASF in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Cell TherapyIndustries

Requirements

Bachelor's degree in STEM field preferred. High school diploma/Associates degree with equivalent combination of education and work experience may be considered
0-2 years of relevant cGMP experience
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy
Ability to understand, follow, and apply approved procedures
Possess basic computer skills with knowledge of MS Office
Ability to understand problems and propose practical solutions
Ability to communicate effectively with cross functional peers and direct management through written and verbal skills
Ability to work in a fast-paced team environment with changing priorities
Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work
Ability to recognize the need for escalation of issues
Self-motivated and willingness to learn

Responsibilities

Provide Quality on-the-floor oversight to Manufacturing/QC/Supply Chain Operations & responding to minor issues or escalating to senior members
Perform and document operational verification per approved procedures
Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques
Provide quality oversight to maintenance operations and support pre-approved return to service plans
Perform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures
Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required
Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects
Maintain compliance with assigned learning plan
Support internal and external inspections as required
Contribute to the assessment of discrepancies and initiation of quality events
Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/knowledge within team
Build relationships within direct team and partner functions

Skills

Quality Assurance

cGMP

Manufacturing Oversight

Quality Control

Supply Chain Operations

Shop Floor Oversight

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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