Job Summary:

This position functions primarily in a controlled-non-classified (CNC) environment and requires the individual to wear appropriate PPE. This position will perform labeling, visual inspection, and other duties, such as cleaning, restocking, and waste destruction, as required and/or assigned.

All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required.

Responsibilities:

• Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.
• Authorized to immediately stop any task that is determined to be an imminent hazard.
• Always promote and demonstrate safe work practices and adhere to PPE requirements.
• Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds.
• Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift.
• All responsibilities of Production Associate I AND the following:
• Learn to operate all relevant automation technology and equipment for labeling and visual inspection operations.
• Obtain and maintain visual inspection qualification for NLT 2 additional unique processes including, but not limited to:
  1. On-Q pumps
  2. IV Bags
• Provide effective leadership, advice, instructions, and training to others regarding operations for labeling, visual inspection, and support processes.
• Demonstrate basic troubleshooting skills and the ability to make recommendations or collaborate on solutions for resolving issues.
• Make minor adjustment to equipment to address issues.
• Complete documentation reviews as required or assigned.

Required Skills/Abilities: (examples)

• Prior cGMP experience.
• Knowledge of FDA guidelines, cGMP, and GDP.
• Willingness to participate in training and gain other certifications as needed.
• Knowledge of basic arithmetic and chemistry calculations.
• Ability to work in a fast-paced environment with dynamic priorities and demands.
• Excellent written and verbal communication skills.
• Desire to expand knowledge and grow with the company.
• Leadership ability.

Education and Experience:

• Prior cGMP experience.
• Knowledge of FDA guidelines, cGMP, and GDP.
• Willingness to participate in training and gain other certifications as needed.
• Knowledge of basic arithmetic and chemistry calculations.
• Ability to work in a fast-paced environment with dynamic priorities and demands.
• Excellent written and verbal communication skills.
• Desire to expand knowledge and grow with the company.
• Leadership ability.

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.