Quality Operations Quality Assurance Specialist

Job overview

The Quality Operations Quality Assurance Specialist role supports daily quality assurance activities at a client site in Morris Plains, NJ; compensation is not specified. The work supports manufacturing, packaging, and laboratory operations in the pharma or healthcare industry. The specialist reviews quality records and procedures, supports investigations and audits, and helps ensure operations comply with cGMP, FDA, and company quality standards. Accurate documentation and inspection readiness contribute to consistent quality operations.

What you'll do

• Review batch records, deviations, CAPAs, and change controls
• provide quality support to manufacturing, packaging, and laboratory operations
• ensure compliance with GMP, FDA, and company quality policies
• participate in investigations and root-cause analysis
• review and approve SOPs, validation protocols, and reports
• support audits and inspection readiness
• maintain QA documentation and records.

What we're looking for

Skills & competencies

quality assurance specialist

quality operations

cgmp

fda compliance

batch records

capa

change controls

sops

validation

audit readiness

pharma

morris plains nj

karwell technologies

Work arrangement

• Weekend coverage required

Why this role

The posting requires a bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field and 3–5 years of Quality Assurance or Quality Operations experience. TrackWise, Veeva, and aseptic or sterile manufacturing experience are listed as nice to have.

About the employer

Karwell Technologies is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.