On-Site QA Specialist: GMP & Manufacturing Oversight

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

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.