Specialist QA Shop Floor - Summit West, NJ

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control Laboratories, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

• Sun-Wed Days - 5:00am-5:30pm
• Wed-Sat Days - 5:00am-5:30pm
• Sun-Wed Nights - 5:00pm-5:30am
• Wed-Sat Nights- 5:00pm-5:30am

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, Label Operations and Supply Chain operations.
• Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
• Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
• Provide quality oversight for pre-planned return to service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
• Identify and propose improvements to programs, procedures, and practices.
• Review manufacturing batch records to ensure compliance with approved procedures.
• Review and provide feedback on documents such as forms, logbooks, and procedures.
• Maintain compliance with assigned learning plan. Provide integration support of newer team members.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
• Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
• Participate in quality and shift meetings.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Share data/knowledge within team by acting as a champion for quality-culture.
• For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles.
• Perform verification and reconciliation of issued drug product labels.

Reports to the Manager, Quality Assurance Shop Floor

High School/GED

• Must be action-oriented and proficient in decision‑making, building relationships, problem‑solving, and analytical thinking.
• Ability to understand, follow, and apply internal policies, procedures, and quality principles.
• Prior experience with quality processes, including but not limited to batch record review, change control, product complaints, deviations, investigations, and CAPA management.
• Ability to assess an unfolding situation, diagnose the problem, and…