Aseptic QC Analyst – GMP Lab

ADP; Mount Laurel Township (NJ); On-site; USD 28,000 - 33,000; Full time

Job summary

Stokes Healthcare is seeking a dedicated laboratory operations candidate in Mount Laurel, NJ to support aseptic processes and quality systems. The role emphasizes cGMP compliance and rigorous documentation in a controlled facility across three divisions.

The position requires education in biology/microbiology or equivalent experience, protective gear handling, and strong communication and problem-solving abilities. Full-time hours, starting at $20/hour with biannual bonuses.

Qualifications

• Bachelor’s degree in biology, microbiology, or other related field, or 1 year relevant experience in cGMP environment
• Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles)
• Must learn and understand 21 CFR Part 210 and Part 211, along with other relevant cGMP regulations
• Must be capable of working with small, delicate pieces of machinery to complete appropriate dosage forms in a timely manner
• Must possess strong verbal, written, and oral communication skills
• Must be able to work independently and with a team
• Must possess problem-solving skills
• Must exhibit punctuality and low absenteeism

Responsibilities

• Learn aseptic gowning and technique within a cleanroom environment
• Learn and apply GxP (GMP, GDP, GLP) to operations
• Perform viable/non-viable environmental monitoring and read/review microbial samples
• Assist in the media-fill process validations and inspection of filled units
• Perform document review of operation activities such as cleaning record, line clearance forms, and inventory/equipment checklist
• Document non-compliance and work with supervisor/lead if further investigation is needed
• Review production batch records and associated data for product release; determine if records are within cGMP regulations; review data obtained for compliance specifications and report abnormalities
• Perform audits on aseptic technique and operation documentation
• Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
• Ensure timely assessment and closure of Change Controls
• Assist with equipment calibration program and maintenance record files
• Identify and assess quality risk in activities and processes according to regulatory guidelines and SOPs
• Assist in the training of new employees and other technical personnel

Skills

Communication skills

Problem solving

Organizational skills

Attention to detail

Teamwork

Punctuality

GxP knowledge

cGMP compliance

Education

Bachelor’s degree in biology/microbiology or related field

1 year relevant experience in cGMP environment

Job description

Stokes Healthcare is seeking a dedicated laboratory operations candidate in Mount Laurel, NJ to support aseptic processes and quality systems. The role emphasizes cGMP compliance and rigorous documentation in a controlled facility across three divisions.

The position requires education in biology/microbiology or equivalent experience, protective gear handling, and strong communication and problem-solving abilities. Full-time hours, starting at $20/hour with biannual bonuses.