QA Specialist - cGMP Release & Investigations

Bristol Myers Squibb; New Jersey; On-site; USD 85,000 - 110,000; Full time

Job summary

Bristol Myers Squibb in New Jersey seeks a Quality Specialist to support cGMP compliant disposition and release of materials and drug products. You will issue controlled documents, review investigations, and contribute to CAPA and change control processes with a focus on accuracy and cross-functional collaboration.

The role requires a college degree and 4+ years of relevant quality operations experience at a manufacturing site, with flexibility to work weekends as needed.

Qualifications

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Is Recognized Subject Matter Expert withing the group.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.

Responsibilities

• Disposition of incoming production materials.
• Release activities for site manufactured drug product.
• Issuance of controlled documents.
• Scans and uploads batch record documents.
• Strong authorship and ability to review investigations and generate technical conclusions.
• Plan and organize, make decisions, and build relationships.
• Knowledge of quality processes including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to multitask and contribute to process improvements in scope.

Skills

cGMP manufacturing

Quality systems

Problem solving

Decision making

Planning & organizing

Communication

Continuous improvement

CAPA management

Education

Bachelor's degree required

Job description

Bristol Myers Squibb in New Jersey seeks a Quality Specialist to support cGMP compliant disposition and release of materials and drug products. You will issue controlled documents, review investigations, and contribute to CAPA and change control processes with a focus on accuracy and cross-functional collaboration.

The role requires a college degree and 4+ years of relevant quality operations experience at a manufacturing site, with flexibility to work weekends as needed.