25 September 2021
Manufacturing Operator II

Job Summary:
Performs the batching of blends for the company's transdermal products and assists in other manufacturing processes for the company's transdermal products (i.e. Coating and Finishing Operations). 
 

Job Responsibilities:
    • Manufactures blend batches with active drug substances and blend on a consistent basis.
    • Leads a crew to coat blends and adhesives to produce laminate and perform the finishing operation on coated laminate.
    • Assembles and disassembles all blending and manufacturing equipment.
    • Weighs and documents the weights of raw materials, components, and product intermediates.
    • Documents operational parameters and steps performed in the batch record.
    • Performs batch record accountability calculations.
    • Assist in the training of manufacturing Operator I’s throughout all manufacturing operations.
    • Works with active drug products, adhesives, solvents, and various other chemicals to perform all steps in the manufacturing process.
    • Documents operational parameters for manufacturing equipment.
    • Complies with Current Good Manufacturing Practices, Standard Operating procedures, and safety policies while performing all job duties.
    • Maintains and cleans manufacturing and production areas and equipment and documents work performed in an appropriate logbook.
  • Performs online coat weight sampling operations.
  • Prepares finished or slit laminate rolls.
  • Performs job tasks within production and other departments as needed.
  • Works as a member of a team to achieve all outcomes.
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
  • All other relevant duties as assigned.
 
Job Requirements
  • Education
  • High school diploma or general education degree (GED) plus a minimum of one year of related experience and/or training; or equivalent combination of education and experience.
 
·       Knowledge, Skills and Abilities
  • Ability to speak English effectively
  • Ability to write English and complete batch record documentation.
  • Ability to read, English and interpret documents such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
  • Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions, and decimals.  Ability to compute rate, ratio, percent, and to plot and interpret data graphically.
  • Ability to apply common sense understanding to carry out detailed written and oral instructions.
  • Mechanical ability to assemble manufacturing equipment. 
  • Knowledge of FDA, DEA, cGMPs, and SOPs related to job requirements.
 
·       Physical Requirements and Working Conditions:
While performing the duties of this job, the employee is regularly required to sit, stand and walk.  The employee is frequently required to use hand to finger, handle or feel; reach with hands and arms; and talk and hear.  The employee is occasionally required to stoop, kneel, crouch, or crawl.  The employee must frequently lift and/or move up to 50 pounds.
While performing the duties of this job, the employee is regularly exposed to moving mechanical parts.  The employee is frequently exposed to fumes or airborne particles and toxic caustic chemicals. The noise level in the work area is usually loud.
The employee will be required at times to wear a full face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection, and other personal protective equipment (PPE) as required. The employee may be required to work additional hours from time to time, including weekends.  Shift hours are subject to change due to operational needs.

Shifsts: 1,2 & 3  (Flexibility required)
  • Experience
    • A minimum of one year experience as a Manufacturing Operator I, or equivalent related experience.