Department

Production

Reports To 

Cleanroom Supervisor

Starting Pay

$20 per hour

Major Responsibilities

• Handling and processing of product in the cleanroom.

• Follow written instructions and procedures to process product.

• Sanitize cleanroom equipment.

• Follow proper garmenting procedures.

• Follow proper documentation.

• Maintain the cleanliness of immediate work areas.

• Inspect product for defects and document irregularities.

• Effectively communicate with management.

• Adhere to cleanroom policies and standards.

• Follow health and safety guidelines.

• Other duties as assigned.

Qualifications

• High School Diploma.

• Requires attention to detail.

• Good problem-solving skills.

• Good oral and written communication skills.

• Ability to lift up to 20 lbs. consistently.

• May require mandatory overtime as necessary.

• Ability to stand on feet for extended periods of time.

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Department

Quality

Reports To 

Sr. Quality Manager

Starting Pay

$26.45 per hour

Major Responsibilities

Personnel and Training

• Ensure Cleanroom B personnel are properly trained before executing any task.
• Confirm adherence to company policies and Good Manufacturing Practices (GMP).

Cleanroom Environment and Workflow

• Maintain orderly placement of materials and equipment to prevent contamination and mix-ups.
• Monitor the proper flow of components, containers, closures, labeling, in-process materials, and drug products.
• Ensure environmental controls such as temperature and humidity are maintained and report to facility department any irregularities.

Equipment and Calibration

• Ensure all equipment in Cleanroom B is properly identified and marked with calibration dates.
• Verify that equipment is clean, within calibration period and ready for use before starting any process.

Manufacturing and Packaging Operations

• Verify proper execution of manufacturing, processing, packaging, and labeling operations.
• Confirm quarantine storage procedures before the release of drug products.
• Inspect and clear packaging lines, printing machines, and other equipment of leftover products or materials.

Inspections and Verifications

• Review and pull required documentation including:
  • Return sheets
  • Visual inspection forms
  • Line clearance forms
  • Work Order forms for in-process products, such as QF 145A, 145B,145C , and other process forms
• Ensure:
  • Pull ware form matches startup products and Work Orders (WO).
  • Water resistivity and TOC testing are performed before washing procedures.
  • Cleanliness of perforated stainless-steel cleaning baskets, cover trays, and cookie trays.
  • Autoclave cleanliness, sterility sticker colors, and strip verification for each WO.
  • Sealers’ temperature settings.
  • Correct labeling and quantities in carts and double-bagging areas.
  • Online product control during processing.
  • Actual and theoretical yields are reconciled after each phase.

Documentation and Reporting

• Review and comprehend:
  • Work Orders
  • Deviation Reports
  • Non-Conformance Material Reports (NCMRs)
  • Out of Specification (OOS) Reports
  • Audit Reports
• Assist in investigations and communicate findings.
• Ensure documentation of inspection results and quality issues is clear and accurate.
• Use Quality logs to report findings and observations.
• Generate QF forms when needed.

Quality Assurance and GMP Compliance

• Ensure compliance with Standard Operating Procedures (SOPs).
• Identify or request new SOPs when needed.
• Perform GMP audits, draft Corrective and Preventive Actions (CAPAs), and report corrective actions to responsible parties.
• Verify that new product launches and process redesigns align with GMP and systematic processes.
• Lead efforts to align Quality Assurance with production and compliance objectives.

Process-Specific Checks

• Conduct:
  • Endotoxin water testing.
  • Inspection of vials and materials for quantity sufficiency.
  • Clearance of intimate packaging areas (e.g., spacers, bag sizes, brackets, vials, etc.).
  • Depyrogenation oven cycle temperature ticket checks.
  • Inspection of line clearance and cleanliness before and after packaging.

Handling Deviations and Rework

• Report deviations and non-conformances immediately.
• Manage workflow for rework or reprocessing as required.
• Ensure proper batch separation through physical or temporal means to avoid confusion.

Audits and Facility Management

• Lead GMP and compliance audits during internal audits.
• Ensure the status of equipment, utilities, and production areas is maintained and labeled accordingly.
• Oversee corrective actions and implement process improvements.

Special Responsibilities

• Expedite rush orders in coordination with the production team.
• Verify physical or spatial separation of products during press runs to prevent mix-ups.
• Improve documentation efficiency as applicable.
• Ensure proper endotoxin water testing and particle testing during validation and production.

Required Skills

• Proficient in operating and inspecting cleanroom equipment (autoclaves, ovens, sealers, ultrasonic washers).
• Knowledge of GMP, FDA, 21 CFR Parts 11, 210, 211 and 820 and ISO 13485, 9001.
• Skilled in maintaining and reviewing quality documentation, including line clearance forms, HEPA filter records, maintenance logs, batch records, and work orders (e.g., QF107, QF82).
• Familiar with CAPA processes and deviation reporting.
• Strong attention to detail for identifying non-conformities and ensuring compliance.
• Effective verbal and written communication for coordination with Quality, Production, and Maintenance teams.
• Capable of maintaining accurate documentation for audits and inspections.
• Understanding of cleanroom standards (contamination Risks).
• Experience inspecting raw materials, in-process products, and packaging in cleanroom environments.
• Knowledge of aseptic processing principles and cleaning validation.
• Proven ability to identify inefficiencies in cleanroom processes and propose improvements.

Qualifications

• High school diploma or equivalent (required); an associate’s or bachelor’s degree in Life Sciences, Quality Assurance, or a related field is preferred.
• Certifications in quality control or cleanroom operations (e.g., ASQ Certified Quality Inspector (CQI) or Cleanroom Technician Certification) are a plus.
• 2 years of experience in quality control roles within a cleanroom environment, preferably in GMP-regulated industries (e.g., pharmaceutical, biotechnology, or medical devices).
• Hands-on experience inspecting manufacturing and packaging operations in cleanrooms.
• Familiarity with cleanroom classifications and environmental monitoring is preferred.

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