Quality Assurance Associate

Spectrum Staffing Services/HRStaffers Inc.; Monroe (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A staffing and staffing services provider is looking for a Quality Assurance professional in Monroe, NJ. You will coordinate investigations, support audits, and manage quality events in a regulated environment. The ideal candidate has a Bachelor's degree and experience in Quality Assurance within a cGMP-regulated manufacturing environment, showcasing strong documentation and organizational skills.

Qualifications

• Experience in Quality Assurance within a cGMP-regulated environment preferred.
• Ability to manage multiple priorities and deadlines.
• Capable of producing accurate and complete documentation.

Responsibilities

• Lead investigations for deviations, OOS events, and non-conformances.
• Draft and execute effective CAPAs.
• Prepare for and support internal/external audits.

Skills

Quality Assurance

Attention to Detail

Documentation Practices

Communication Skills

Education

Bachelor’s degree or equivalent

Tools

Electronic QMS tools

Job description

Overview

Join a quality-focused team ensuring products and processes meet rigorous standards. In this role, you’ll coordinate deviation investigations, support audits and inspections, own quality event tracking within an electronic QMS, and help drive continuous improvements. You’ll collaborate across functions on CAPAs, change controls, supplier qualification, and annual product reviews—building hands-on experience in a regulated manufacturing environment.

Responsibilities

• Lead/coordinate investigations for deviations, LIRs, OOS events, and non-conformances; document findings and track actions to closure.
• Draft and execute effective CAPAs that address true root cause and prevent recurrence; verify effectiveness over time.
• Evaluate and process change controls with risk assessments and stakeholder coordination.
• Prepare for and support internal/external audits and inspections; help compile evidence and respond to observations.
• Manage quality events and controlled documentation in the electronic QMS (e.g., change controls, deviations, OOS, complaints).
• Log, triage, and coordinate product complaint handling per established procedures.
• Compile quality metrics and trends; present insights during regular quality reviews (biweekly/monthly).
• Assemble Annual Product Review/Annual Product Quality Review (APR/APQR) reports with cross-functional inputs.
• Support vendor/supplier qualification activities and maintain required records.
• Communicate with suppliers/vendors for qualification documentation and regulatory filing needs.
• Champion good documentation practices (GDP) and site-wide continuous improvement initiatives.
• Perform additional quality tasks as assigned to meet operational needs.

Qualifications

• Bachelor’s degree preferred (or equivalent combination of education and experience).
• Experience in Quality Assurance within a cGMP-regulated pharmaceutical/biologics manufacturing environment preferred.
• Familiarity with controlled documents and electronic QMS tools.
• Clear, concise written and verbal communication; strong interpersonal skills for cross-functional teamwork.
• Highly organized with strong attention to detail; able to manage multiple priorities and deadlines.
• Ability to interpret technical information and produce accurate, complete documentation.
• Capable of working at a computer for extended periods and traversing operational areas as needed; able to occasionally lift up to 25 lbs.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance
• Industries

Location mentioned: Monroe, NJ.