JOB DESCRIPTION

Position Summary

This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, 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 overtime and/or weekends, may be required.

Safety and Responsibilities

SAFETY

• 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.
   
   

PRIMARY RESPONSIBILITIES:

• Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements.
• Learn to utilize all relevant equipment/technology for filling operations.
• Responsible for acquiring and maintaining classified area gowning qualification.
• Complete and document required training to gain proficiency for all assigned job tasks.
• Accurately and contemporaneously document all actions performed per GDP standards.
• Assist with classified and non-classified area cleaning and maintenance as required.
• Perform visual inspection, labeling, and additional support tasks as required.
• Make recommendations for process improvements.
• Possess the ability to master multiple processes across different areas.
• Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.
• Maintain a quality focused, “Right First Time”, attitude.
   
   

Values and Behaviors

• Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.
• Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.
• Ensure patient safety by understanding you and your team’s impact on product quality.
• Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. 
• Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
• Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.  

Required Qualifications and Education 

• High School Diploma or equivalent.
• Must pass a drug test.
• Must speak, write, and read English.
• Must be a team player.
• Must have excellent attention to detail.

Preferred Skills

• Prior Sterile Compounding and Pharmaceutical Industry experience.
• Prior experience operating manufacturing equipment/machinery.
• 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.