Operator I

Location: Davie, FL Shift Schedule: Monday - Friday 6:00 am - 2:30 pm EST (Two 30-minute lunch breaks each)

Core Essential Skills: 1) looking for someone who is engaged, motivated, dependable, wants to learn, and interested in building a career within the pharmaceutical industry. Someone who is comfortable working in a fast-paced environment and retains information. The role will initially involve responsibilities such as preparing and cleaning drums, wiping equipment with alcohol wipes, staging materials, and learning the department's processes. There may be future opportunities to take on additional responsibilities and potentially progress into a Pharmacy Operator role. 2) High school diploma or GED certificate 3) At least 1 year in last 2 positions. 4) Comfortable climbing ladders up to 15ft and rolling pallets up to 75 pounds using lifters All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions. Perform dispensing and weighing of raw materials according to batch records, dispensing orders, and approved procedures. Verify material identity, lot numbers, expiration dates, quantities, and status labels prior to use. Operate dispensing equipment, scales, barcode systems, material handling devices, and associated systems. Maintain accurate documentation within batch records, logbooks, inventory systems, and electronic records. Complete reconciliation of materials, labels, and documentation. Monitor inventory levels and communicate material shortages or discrepancies. Perform line clearance, area readiness, and room status checks. Maintain cleanliness of dispensing rooms, equipment, and work areas. Perform basic troubleshooting and report equipment or process issues. Support investigations, deviations, CAPAs, and continuous improvement initiatives. Adhere to cGMP, GDP, safety, environmental, and quality requirements. Ensure 100% completion of assigned training. Communicate effectively during shift handoffs and with cross-functional teams. Support production schedules through timely material availability. Perform related duties as assigned. Responsible for completing all training requirements and maintaining 100% compliance with all assignments. Reports process or equipment problems to supervisor; performs minor or basic troubleshooting. Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation. Maintains records of manufacturing process by recording data on batch record. Sets-up and operates equipment for processing operations. Communicates effectively with previous and incoming shift operator and related personnel. Cleans and maintains processing rooms and equipment. Monitors process and equipment and makes necessary adjustments to maintain batch record specifications. Monitors product quality. Performs reconciliations. Conducts in-process testing. Checks and adjusts calculations. Checks/reviews labels and batch records for accuracy. Understands concept of delivery/on-time production. Follows established department SOP's and batch record instructions. Complies with all Company policies and procedures, including safety rules and regulations. Responsible for performing additional related duties as assigned.

POSITION REQUIREMENTS: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Education/Certification/

Experience: Requires High School Diploma or equivalent with a minimum of 0-1 year relevant progressive manufacturing experience, preferably in the pharmaceutical industry. Skills/Knowledge/Abilities: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. Proper English grammar and punctuation. Effective oral and written communication skills. Basic math skills. Working independently as well as in a team environment. SOP's, cGMP's, equipment and safety practices. GMP compliance in a regulated work environment. Manufacturing processes and equipment procedures. Record keeping skills. Providing excellent customers service with both internal and external customers. Ability to use material handling equipment. Complying with all Company safety rules and regulations. Problem Solving: Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required. Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions. Normally receives general instruction on routine work and detailed instruction on new assignments. May be asked to recommend methods and procedures for problem resolution.