Manufacturing Associate - Cleanroom

Manufacturing Associate - Medical Device - 1st, 2nd, 3rd Shift Job Description

The Cleanroom Technician supports daily production and packaging activities in a regulated manufacturing environment, ensuring all work complies with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and standard operating procedures (SOPs). This role focuses on achieving production goals, maintaining product quality, and accurately documenting all activities while working in a cleanroom setting with strict safety and cleanliness standards.

• Perform daily production and packaging activities in accordance with GMP and all applicable SOPs.

• Work consistently to achieve assigned production goals and support unscheduled workload peaks to ensure timely product release and prevent back orders.

• Collaborate with the Team Leader and other stakeholders to understand critical raw materials, in-process procedures, and product specifications.

• Identify technical issues related to raw materials and finished products and assist in implementing appropriate corrective actions.

• Perform in-process quality checks on sub-assemblies and finished products to verify compliance with specifications.

• Recognize line issues and other production problems and promptly notify the Team Leader or appropriate personnel for corrective action.

• Maintain accurate, complete, and legible records and documentation in accordance with GDP and related SOPs.

• Use a computerized Materials Resource Planning (MRP) or Enterprise Resource Planning (ERP) system to report lot-controlled ingredients and accurately complete batch records.

• Perform line clearances and verify that equipment, materials, and documentation are correctly set up and cleared between production runs.

• Operate manufacturing and packaging machinery safely and efficiently, following all SOPs and work instructions.

• Support qualification and validation activities as needed by following defined protocols and documenting results.

• Adhere to Good Laboratory Practices (GLP), FDA, ISO, and other relevant regulatory and quality standards as required.

• Follow cleanroom protocols, including gowning procedures, cleanliness standards, and restrictions on personal items and cosmetics.

• Use computers and related systems to close work orders and document production activities accurately.

• Participate in overtime and weekend work as needed, including potential Saturday shifts, based on production demands.

• Demonstrate reliable attendance and punctuality to avoid bottlenecks in the production process and maintain workflow continuity.

• At least four years of previous assembly and packaging experience in a manufacturing environment.

• Previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.

• Strong understanding of standard operating procedures (SOPs), including the ability to explain what SOPs are and how they are applied in a manufacturing environment.

• Ability to provide detailed examples of how SOPs were followed in prior roles to achieve production and quality goals.

• Solid understanding of Good Documentation Practices (GDP), including the ability to explain GDP and describe how they were applied in previous positions.

• Working knowledge of Good Manufacturing Practices (GMP) and their application in daily production activities.

• Familiarity with Good Laboratory Practices (GLP), FDA regulations, and ISO standards.

• Ability to perform line clearances and provide accurate examples of prior line clearance responsibilities.

• Experience with machine operation in a production or packaging environment.

• Experience with quality assurance, inspection, and in-process quality checks.

• Computer operation skills, including the ability to use MRP or ERP systems to record lot-controlled ingredients and close work orders.

• Working knowledge of Microsoft Office applications.

• Previous experience with, or the ability to quickly comprehend, coagulation-based manufacturing processes.

• Strong attention to detail and accuracy in documentation and record-keeping.

• Ability to understand and use manufacturing terminology and acronyms, demonstrating familiarity with manufacturing…