Manufacturing Associate

Clinlab Solutions Group; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

Clinlab Solutions Group is seeking personnel to sustain GMP readiness in cleanrooms of a pharmaceutical facility in New Jersey. The role emphasizes routine and ad-hoc cleaning, environmental monitoring, and material flow support to safeguard contamination control and patient safety.

The position requires a science-based degree (or an associate’s with GMP experience), strong documentation skills, and the ability to work cross-functionally.

Qualifications

• Bachelor’s degree in a science-based discipline or an associate’s degree with 1–3 years GMP-regulated work.
• Familiarity with environmental monitoring methods and Good Documentation Practice (GDP)
• Strong attention to detail with the ability to follow SOPs and GDP requirements.
• Strong teamwork and communication skills with flexibility to support cross-functional needs.

Responsibilities

• Perform routine cleaning and environmental monitoring of classified cleanrooms following SOPs and regulatory expectations (cGMP).
• Complete logs and documentation to ensure GDP compliance.
• Support inspection readiness by maintaining cleanroom standards and addressing deviations promptly.
• Safely transfer materials and equipment within the facility.
• Assist production staff with ancillary tasks and equipment setup as needed.
• Adhere to GMP, GDP, and safety requirements during all activities.
• Maintain training status including aseptic gowning qualification and requalification.
• Identify and escalate deviations observed during cleaning or material handling.
• Lead training activities for cleaning and environmental monitoring.

Skills

Attention to detail

Teamwork

Documentation

Regulatory compliance

Cross-functional support

Education

Bachelor's degree in science

Associate’s degree with 1–3 years GMP experience

Tools

GMP documentation systems

Job description

Sustain GMP readiness of cleanrooms by executing routine and ad-hoc facility sanitization, performing viable and non-viable environmental monitoring, supporting material/equipment/product flow throughout the facility, and providing production support. The role is highly detail-oriented, documentation-driven, and integral to contamination control and patient safety.

Key Responsibilities

• Perform routine scheduled and ad hoc cleaning and environmental monitoring of classified cleanrooms in accordance with SOPs, cGMP requirements, and regulatory expectations
• Accurately complete cleaning and environmental monitoring logs and documentation to ensure GDP compliance
• Support inspection readiness by maintaining cleanroom standards and addressing deviations promptly
• Safely transfer raw materials, consumables, drug product, waste, and equipment throughout the facility including classified locations
• Support material staging and preparation to enable timely manufacturing operations
• Assist production staff with ancillary support tasks as needed, such as cryopreservation transfer tasks and equipment setup.
• Adhere strictly to GMP, GDP, and safety requirements during all activities
• Maintain training status including aseptic gowning qualification and requalification
• Identify and escalate any deviations or anomalies observed during cleaning, EM, or material handling
• Lead training activities for cleaning and environmental monitoring

Required Qualifications

• Bachelor’s degree in a science-based discipline (e.g., biology, chemistry, biotechnology) or, associate’s degree with 1–3 years of experience in a GMP-regulated work
• Familiarity with environmental monitoring methods and good documentation standards
• Strong attention to detail with proven ability to follow SOPs and GDP requirements
• Strong teamwork and communication skills with flexibility to support cross-functional needs