QA Specialist

Bristol Myers Squibb; New Jersey; In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

cGMP manufacturing

Quality systems

Problem solving

Decision making

Planning & organizing

Communication

Continuous improvement

CAPA management

Formazione

Bachelor's degree required

Descrizione del lavoro

Work Schedule: Mon-Fri (need to be flexible to work on weekends)

Position Summary:

The Specialist is responsible for quality and disposition activities in accordance with Client policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance performing document issuance for manufacturing.

Duties/Responsibilities:

• Responsible for disposition of incoming production materials
• Responsible for release activities for site manufactured drug product.
• Issuance of controlled documents.
• Scans and uploads batch record documents.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complains, deviations, investigations, and CAPA management.
• Able to effectively multitask.
• Contributes to process improvements in her/her scope of activity.

Qualifications:

Required Competencies: Knowledge, Skills, and Abilities

• 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.

Education/ Experience/ License/Certification

• Relevant college or university degree required.
• Minimum 4 years relevant work experience (or equivalent combination of education and experience).