GMP Quality Control Analyst – Pharma Lab

Epicur; Mount Laurel Township (NJ); On-site; USD 23,000 - 32,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

401(k) with match

Bonus program

Paid holidays

Vacation time

Personal time

Job summary

Stokes Healthcare in Mount Laurel, NJ is seeking an individual to collaborate with production personnel to optimize quality aspects of operations. The role involves aseptic gowning, applying GxP, environmental monitoring, and documentation review to ensure regulatory compliance.

The position requires a Bachelor’s degree in biology/microbiology or 1 year of cGMP experience, ability to wear protective gear, and strong communication skills.

Qualifications

• Bachelor’s degree in biology, microbiology, or related field, or 1 year relevant cGMP experience.
• Able to wear all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles).
• Follow gowning/garbing procedures (no makeup, remove jewelry before sterile compounding).
• Learn 21 CFR Part 210 and Part 211, along with other cGMP regulations.
• Work with small, delicate machinery to complete dosage forms in a timely manner.
• Strong verbal, written, and oral communication skills.
• Able to work independently and with a team.
• Problem-solving skills.
• Punctuality and low absenteeism.
• Able to sit/stand 8-10 hours or more per day.

Responsibilities

• Learn aseptic gowning and technique in a cleanroom environment.
• Apply GxP (GMP, GDP, GLP) to operations.
• Perform environmental monitoring and read/review microbial samples.
• Assist in media-fill process validations and inspection of filled units.
• Review cleaning records, line clearance forms, and inventory/equipment checklists.
• Document non-compliance and escalate with supervisor/lead as needed.
• Review production batch records for cGMP compliance and report abnormalities.
• Audit aseptic technique and operation documentation.
• Ensure completeness and accuracy of all documents and records.
• Assist with closure of Change Controls.
• Assist with equipment calibration program and maintenance records.
• Identify and assess quality risks per regulatory guidelines.
• Assist in training of new employees and other technical personnel.

Skills

Communication

Teamwork

Regulatory compliance

Problem solving

Attention to detail

Education

Bachelor’s degree in biology, microbiology, or related field

1 year relevant experience in cGMP environment

Job description

Stokes Healthcare in Mount Laurel, NJ is seeking an individual to collaborate with production personnel to optimize quality aspects of operations. The role involves aseptic gowning, applying GxP, environmental monitoring, and documentation review to ensure regulatory compliance.

The position requires a Bachelor’s degree in biology/microbiology or 1 year of cGMP experience, ability to wear protective gear, and strong communication skills.