Chemical Process Operator I – 3rd Shift

• Regular and predictable onsite attendance and punctuality.
• Sets up & operates equipment such as scales, mixers, pumps, CIP units, tanks and material handling equipment.
• Maintains accurate records, i.e., log books, raw material inventories, reconciliations and batch records.
• Moves raw material as required for mixing, weighing and storage.
• Weighs all chemicals to prepare cleaning solution batches and on a limited basis, production batches designated by the department.
• Performs acid/base pH adjustments as required by batch or as instructed by QA Lab.
• Transfers finished batches to specified area for further processing.
• Adheres strictly to cGMPs and SOPs to ensure the quality and integrity of products.
• Performs clean-up of equipment and rooms as necessary.
• Collects samples, performs other quality checks as necessary.
• Performs preventive maintenance tasks on compounding equipment, such as tanks, mixers and pumps as required or as instructed by supervisor or designee.
• Refers process issues to supervisor or designee.
• Informs supervisor of maintenance and/or safety issues.
• Works overtime with short notice when production requires.
• Under supervision, weighs specified quantities and follows formulation procedures in the preparation of bulk solutions.
• The incumbent may perform other duties as assigned by management personnel.

• Minimum:
  High School Diploma with 1 year of experience working in a cGMP facility
• Preferred:
  Associates Degree in Science or Equivalent
• Minimum: 1-year of working in a cGMP Facility or 1-year Pharmaceutical liquid batching experience with a High School diploma.
• Good oral and written communication skills are essential.
• Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form
• Must be able to read and understand complex formulation procedures.
• Ability to deal with problems involving several concrete variables in standardized situations.
• Ability to examine problem areas and make recommendations for corrective action.
  
  Must be able to comprehend and follow all applicable SOPs.
• Heavy continuous exertion.
• Movement and weighing of heavy containers up to 100 lbs., lifts 45 – 50 lbs. 25 – 50% of time.
• Movement of portable tanks may require the use of a power pusher which requires 20/40 distance vision and ability to pass a whisper test (or have no worse than 40 dBA in the better ear).
• Must be able to stand for long periods of time.
• Must be able to climb ladders and platforms to dispense chemicals.
• Must be able to wear required PPE.
• Work involves exposure to raw materials which requires special handling and protective equipment. Operators are exposed to raw materials 80% of the time.
• Must work in compounding suites wearing company issued frock (long laboratory coat), hood, and boots.
• Must wear PAPRS and successfully complete and pass pulmonary function testing.
• The noise level is moderate to loud in CIP Washrooms; use of hearing protection may be required.

Demonstrates expertise in cGMP compliance and SOP adherence while effectively operating and maintaining compounding equipment. Proficient in chemical weighing, formulation procedures, and quality checks to ensure product integrity.

• CGMP Compliance
• Chemical Weighing
• Formulation Procedures
• Preventive Maintenance
• Quality Control

• Chemical Weighing
• PH Adjustments
• Batch Record Maintenance
• Material Handling
• Preventive Maintenance
• Log Book Documentation
• Mathematical Calculations
• Quality Checks
• Equipment Operation
• Formulation Procedures

• Good Oral Communication
• Good Written Communication
• Problem-Solving
• Attention to Detail

• CGMP Facility
• Pharmaceutical Batching
• SOP Compliance
• Quality Assurance
• Safety Procedures

• CIP Units
• Mixers
• Pumps
• Scales
• Tanks