Specialist QA Shop Floor - Summit West, NJ

MSCCN; Bend (OR); On-site; USD 48,000 - 58,000; Full time

Job summary

Summit West in New Jersey is seeking a Quality Assurance professional to oversee shop-floor quality activities, ensure compliance with cGMP, and collaborate with Manufacturing, QA Labs, and Supply Chain teams. You will review records, support deviations, and drive continuous improvement in a fast-paced environment.

The role requires a strong background in pharma quality systems, MES/SAP/LIMS, and the ability to communicate effectively across cross-functional teams. On-site role based in NJ.

Qualifications

• Must be action-oriented with strong problem-solving and analytical skills.
• Experience with quality processes including batch records, deviations, CAPA.
• Ability to work in fast-paced, cross-functional teams with deadlines.
• Experience with quality management systems and MES/SAP/LIMS.

Responsibilities

• Provide routine on-the-floor quality oversight and triage events.
• Interpret problems and communicate clearly to management.
• Review batch records for compliance and identify deviations.
• Approve deviation records within the quality management system.
• Participate in quality and shift meetings.

Skills

Decision-making

Relationship-building

Problem-solving

Analytical thinking

Communication skills

Data-driven

Team collaboration

Attention to detail

Education

Bachelor's degree in STEM field

High school diploma or associate's degree with equivalent

Tools

MES

SAP

LIMS

Electronic logbooks

Job description

ATTENTION MILITARY AFFILIATED JOB SEEKERS- 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.

Position Summary

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.

Shifts

• 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

Duties / Responsibilities

• 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.

Reporting Relationship

Reports to the Manager, Quality Assurance Shop Floor

Additional Qualifications/Responsibilities

Qualifications

Specific Knowledge, Skills, Abilities

• 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 propose practical solutions.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
• Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
• Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand diverse working perspectives.
• Contributes to a positive team environment.
• Able to independently make decisions based on data and facts, and recognizes when to escalat
• Seeks opportunities for improvement to quality and operational problems.
• Ability to work within pharmaceutical cleanroom environments.
• Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
• Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

Education/Experience/Licenses/Certifications

• Bachelor's degree in STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is considered.
• 2+ years of relevant cGMP experience with 1+ years of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

• Summit West - NJ - US: $34.92 - $42.32per hour

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.