Performs all tasks associated with the preparation, formulation, sterilization, dispensing, inspecting, labeling, and packaging of manufactured products according to cGMP Guidelines in order to meet production demands. Performs all tasks associated with the Sterile Core production area as well as providing backup support for the Cold Products Packaging and Aseptic Suite Group.

Work Schedule: Monday - Thursday 5:30am - 4:00pm. Weekend and off-shift overtime as needed.

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's and FDA regulations.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the area.
• This position will coordinate with Staging, Warehouse, Label Control, and Production Supervisors to plan, schedule, and execute all aspects of the area.
• Monitor and inspect product quality to ensure compliance with standards and specifications.
• Must pass Visual Acuity and Color Vision Test.
• Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
• Follow all written procedures and verbal instructions.
• Perform Batch Record calculations and maintain all documentation according to cGMP Guidelines.
• Follow detailed instructions and communicate effectively, both written and verbally.
• Set up, operate, monitor, and clean production equipment and processes in accordance with current good manufacturing practices and standard operating procedures.
• Order and maintain inventory of materials and supplies.
• Act as demonstrators and/or qualifiers for processes and procedures during the training of new employees.
• Assist in developing and revising SOPs as needed.
• Troubleshoot problems with equipment, devices, or products.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• High school diploma or GED equivalent is required. Associate degree is preferred.
• One or more years of relevant work experience in manufacturing required (regulated environment, attention to detail, and following detailed instructions).
• Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards preferred.
• Willingness to work rotating shifts, weekends, and overtime, as necessary.
• Effectively adjusts to changes and deals effectively with uncertainties in the workplace.
• Ability to generate new and valuable ideas and effective solutions to difficult problems; connects previously unrelated notions.
• Realizes the worth of all people and respects others, regardless of background or cultural differences.
• Thoroughly understands the needs of internal/external customers and making customer satisfaction a top priority.
• Strong motivation and ability to achieve work goals and quantifiable business results.
• Ability and desire to cooperate, collaborate, and partner with others.
• Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
• Demonstrated use of logical methods to solve problems with effective solutions and able to make quick quality decisions.
• Dedicated to providing the highest quality product and meeting the expectations and requirements of internal and external customers.
• Takes ownership and accountability for the production process, assigned production area, production equipment and associated documentation.
• Good interpersonal skills and ability to communicate information in a timely manner.
• Uses his/her time effectively and efficiently; concentrates his/her efforts on the more important priorities for the department.
• Knows personal strengths, weaknesses, opportunities and limits; seeks feedback and open to criticism.
• Demonstrated willingness to be flexible and adaptable to the needs of the department and business.
• Enjoys the challenge of unfamiliar tasks.
• Consistently demonstrates the functional and technical knowledge and skills to do the job at a high level of accomplishment and proficiency.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8 hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.