Senior Specialist, QA Operations at Bristol-Myers Squibb

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, RadiopharmaceuticalsIndustries

Requirements

BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry
Experience working in a GMP aseptic manufacturing environment preferred
Experience working with FDA or other regulatory

Responsibilities

Build and maintain cross functional relationships to improve processes and resolve issues
Provide quality oversight on manufacturing and validation activities
Perform real time review of manufacturing records
Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures
Provide guidance on the handling of quality and shop floor activities
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation
Identify and report discrepancies from required work practices or procedures to management
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate
Participate as requested in the response team for audits and inspections by health authorities

Skills

GMP

Quality Assurance

Batch Disposition

Material Disposition

Regulatory Compliance

Shop Floor Oversight

QA 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

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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