Job description

Shift Available:

Sunday - Wednesday 12-hour shift (every other Wed off)

• 5 p.m. to 5:30 a.m.

Wednesday to Saturday 12-hour shift (every other Wed off)

• 5 p.m. to 5:30 a.m.

Wednesday to Saturday OR Sunday to Wednesday - 12-hour shift (every other Wed off)

• 4 p.m. to 4 a.m.

Wednesday to Saturday OR Sunday to Wednesday - 12-hour shift (every other Wed off)

• 6 a.m. to 6 p.m.

The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing a real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. Must be available to work weekends and off shifts.

Responsibilities:

• Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements and resolve issues
• Perform QA shop floor activities, focused on Manufacturing Operations
• Ensure compliance with applicable procedures and production requirements
• Perform real-time review of manufacturing records. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
• Seeks management guidance on complex issues.
• Develops and revise procedures.

Knowledge & Skills:

• Must be action-oriented and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
• Understands continuous improvement and improves efficiency and productivity within the group or project
• Builds relationships internally within and with cross-functional teams. Contributes to goals within the workgroup
• Ability to direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
• Possess sound knowledge of FDA-regulated cGMP Quality Manufacturing operations and processes and global cGMP requirements
• Must be skilled in planning and organizing, decision-making, and building relationships
• Knowledge of quality processes, including material disposition, material storage, and handling requirements, change control, product complaints, deviations, investigations, and CAPA management
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Possess an independent mindset. Work is self-directed
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
• Confident in making decisions for non-routine issue
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
• Able to prepare written communications and communicate problems to management with clarity and accuracy
• Excellent verbal and written communication skills

Basic Requirements:

• High School Diploma/GED
• At least six months of experience working in a GMP Aseptic manufacturing environment
• Experience in FDA-regulated cGMP Quality Manufacturing operations and processes.
• Available for weekend and off-shift hours

Preferred Requirements:

• Bachelor’s Degree preferred
• 5 years of cGMP Quality Manufacturing operations and processes work experience.
• Quality Assurance Shop Floor Manufacturing roles/experience highly desired (Ex. Quality Operations, In-process QA, IPQA, Quality Inspectors).

Working Conditions:

• Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used.
• Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time.
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

Job Type: Contract

Salary: $25.00 - $30.00 per hour

Schedule:

• 12 hour shift

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Required)

Experience:

• FDA-regulated cGMP: 2 years (Required)
• Manufacturing: 2 years (Required)

Shift availability:

• Day Shift (Required)
• Night Shift (Required)
• Overnight Shift (Required)

Work Location: In person

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