Job Summary:

This entry-level Operations position functions as part of the Production Team and independently performs labeling, visual inspection, and other duties, such as cleaning, restocking, as required and/or assigned.

This position functions primarily in a controlled non-classified (CNC) environment and requires the individual to wear appropriate PPE.

Performs all job functions in adherence with cGMP, company policies, and any other quality or regulatory (e.g., OSHA, DEA, FDA, etc.) requirements.

Duties/Responsibilities:

SAFETY

• Strictly adheres to all regulatory requirements, health and safety (e.g., OSHA, EPA, RCRA) requirements, procedures, work instructions, and corporate policies.
• Immediately stops any task that is determined to be an imminent hazard.
• Promotes and demonstrates safe work practices and adhere to PPE requirements.
• Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds.
• Demonstrates physical ability to lift a minimum of 50 lbs. and push/pull pallets, product containers, etc., multiple times per shift.

PRIMARY RESPONSIBILITIES:

• Assist with non-classified area cleaning and maintenance as required.
• Executes all processes as defined in the batch record, procedures, and work instructions consistent with regulatory/cGMP requirements. 
• Performs Visual Inspection of finished products.
• Performs Labeling and Packaging of finished products.
• Maintains training and qualification in all areas as required.
• Demonstrates basic troubleshooting skills. 
• Uses equipment according to procedures and work instructions.
• Completes cGMP documentation reviews as required or assigned.
• Performs other duties as assigned.
• Demonstrates ability to recognize and respond to potential deviations from the defined process. 

Required Skills/Abilities: 

• Demonstrates ability and motivation to progress to a Production Technician II and/or master multiple processes within assigned work area. 
• Demonstrates accountability by arriving at work at scheduled start time, prepared to work in the CNC or classified environment for most of each shift. Recognizes individual and team deviations and accepts responsibility for making corrections and improvements. 
• Demonstrates integrity by maintaining high ethical standards and treats all employees with trust, respect, and professionalism. 
• Speaks up and holds others accountable by providing constructive feedback. 
• Ensures patient safety by understanding individual and team impact on product quality.
• Participates effectively on a diverse and high performing team. Remains open to new ideas and perspectives, communicate across shifts as required, and complies with procedures to create a safe work environment. 
• Demonstrates motivation by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
• Demonstrates courage and innovation by speaking up about viable options for improvements and supporting a path for implementation.  

Education and Experience:

• High School Diploma or equivalent.
• Must pass drug screening and vision screening.
• Must speak, write, and read English.
• Must be a team player.
• 1+ years of continuous work experience
• Prior experience in a regulated manufacturing industry.
• Knowledge of basic arithmetic and chemistry calculations.
• Ability to work in a fast-paced environment with dynamic priorities and demands
• Must have excellent attention to detail.

Physical Requirements: 

Must be able to left up to 50 pounds at times.

Prolonged periods of standing/sitting.