Specialist, Quality Assurance Shop Floor
Bristol-Myers Squibbabout 1 year ago
Summit, New Jersey, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Position Overview
The Quality Assurance Specialist on the Shop Floor at Bristol-Myers Squibb is responsible for ensuring compliance with manufacturing operations in accordance with company policies and global cGMP standards. This role involves real‐time review of manufacturing records, collaboration with various departments to resolve quality issues, and directing quality initiatives to enhance site efficiencies. The position requires availability for weekend and off‐shift work, emphasizing the importance of flexibility and teamwork in a dynamic environment.
Key Responsibilities
- Build and maintain relationships with Manufacturing Operations, Quality Control, and other departments.
- Perform QA shop floor activities focused on Manufacturing Operations.
- Ensure compliance with applicable procedures and production requirements.
- Conduct real‐time review of manufacturing records and logbooks.
- Critically review investigations, interpret results, and generate technical conclusions.
- Direct quality initiatives for continuous improvement and enhance site quality system efficiencies.
- Recognize and resolve Quality issues, informing management of proposed solutions.
- Develop and revise procedures as necessary.
Required Qualifications
- Associate degree with 1 year of experience in a manufacturing GMP aseptic environment.
- 1 year of Quality Assurance experience within a cGMP environment.
- 1 year of deviation experience, including strong technical writing skills.
- Ability to work weekends and off‐shift hours.
Preferred Qualifications
- Bachelor's Degree preferred.
- 3 years of cGMP Quality Manufacturing operations experience.
- Experience in Quality Assurance Shop Floor roles such as Quality Operations or In‐process QA.
Benefits & Perks
- Competitive salary and benefits package.
- Opportunities for career growth and development.
- Support for work-life balance and flexibility.
Required Skills
cGMP Compliance
Manufacturing Operations
Deviation Management
Manufacturing Records Review
Technical Writing
Quality Assurance
Process Improvement
Team Collaboration