Environmental QC Analyst | cGMP Lab & Aseptic Monitoring

Stokes Pharmacy; Mount Laurel Township (NJ); On-site; USD 42,000 - 55,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(K) retirement with employer match

Bonus program

Paid holidays, vacation and personal时间

Job summary

Stokes Pharmacy in Mount Laurel, NJ is seeking a quality-focused professional to join our sterile operations team. The role emphasizes aseptic gowning, GxP applications, environmental monitoring, and documentation to ensure regulatory compliance.

You will work Monday–Thursday 10AM–8PM, full-time, with a starting wage of $20.00 per hour plus annual bonuses. Candidates should have a biology/microbiology background or related cGMP experience and be able to wear full protective gear.

Qualifications

• Bachelor’s degree in biology, microbiology, or related field or 1 year relevant experience in a cGMP environment.
• Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles).
• Must follow gowning/garbing procedures and avoid makeup or jewelry in sterile environments.
• Must learn 21 CFR Part 210 and 211 and other cGMP regulations.
• Ability to work with small, delicate machinery to complete dosage forms.
• Strong verbal, written, and oral communication skills.
• Must be able to work independently and with a team.
• Must possess problem-solving skills and be punctual with 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 media-fill process validations and inspection of filled units.
• Perform document review of operation activities such as cleaning records and inventories.
• Document non-compliance and coordinate with supervisor for further investigation.
• Review production batch records for cGMP compliance and report abnormalities.
• Perform audits on aseptic technique and operation documentation.
• Ensure completeness and accuracy of documents and systems.
• Assist with Change Controls and calibration program maintenance.
• Identify and assess quality risk per SOPs and regulatory guidelines.
• Assist in training new employees and technical personnel.

Skills

Gowning procedures

GxP knowledge

Environmental monitoring

Documentation

Team communication

Education

Bachelor’s degree in biology or microbiology

1 year relevant cGMP experience

Job description

Stokes Pharmacy in Mount Laurel, NJ is seeking a quality-focused professional to join our sterile operations team. The role emphasizes aseptic gowning, GxP applications, environmental monitoring, and documentation to ensure regulatory compliance.

You will work Monday–Thursday 10AM–8PM, full-time, with a starting wage of $20.00 per hour plus annual bonuses. Candidates should have a biology/microbiology background or related cGMP experience and be able to wear full protective gear.