Senior Specialist, Quality Assurance Lot Disposition at Bristol-Myers Squibb

Bothell, Washington, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Cell TherapyIndustries

Requirements

Full-time availability with 4 x 10hr shifts (Sat-Mon and Wed 8am-6pm), including weekends and holidays
Ability to work in a typical office environment, generally seated, with up to 10% standing/walking
Expertise in cGMP standards, lot disposition, and quality assurance processes
Proficiency with electronic systems such as MES (Manufacturing Execution System) and ERP (Enterprise Resource Planning System)
Experience reviewing and approving Certificates of Analysis, lot genealogy, deviations, batch records, and other quality documents
Capability to act as subject matter expert during audits and regulatory inspections

Responsibilities

Conduct routine lot disposition activities for finished drug products and incoming raw materials, ensuring all documentation is accounted for, completed, and approved under cGMP standards
Generate, review, and approve Certificates of Analysis against release specifications, ensuring EM data approval and excursion documentation in QMS records
Collaborate with stakeholders and management, communicate lot disposition status, monitor progress, and issue status reports
Review lot genealogy for all raw materials and components used in each drug product lot to ensure approval and release via MES or ERP systems
Perform drug product lot disposition process and generate, review, approve Release For Infusion (RFI) documentation
Assemble and review quality system documents such as deviations, batch production records, test methods, specifications, and controlled forms for each lot
Create and revise Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, and Reference Documents as needed
Support internal and external audits, CAPAs, change controls, and other QA department needs
Champion and foster a positive quality culture aligned with BMS’s culture
Support continuous improvement projects to enhance manufacturing and business process efficiency
Represent Quality unit at project meetings, provide quality input for issue resolution
Act as subject matter expert for QA oversight of cGMP operations during audits and regulatory inspections

Skills

cGMP

Quality Assurance

Lot Disposition

Certificate of Analysis

EM Data Review

QMS

Raw Materials Release

Drug Product Release

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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