Gel Prep Operator

Summary To provide a cGMP compliant manufacturing process for manufacturing dietary supplements under 21 CFR.111 and 117. Gelatin Operators prepare, blend and mix batches of gelatin by operating gel melting equipment and completing batch paperwork according to Standard Operating Procedures+ Key Responsibilities Follows all Standard Operation Procedures (S.

O.P.’s) relating to processes. Immediately brings any discrepancies to the attention of a supervisor before continuing in processes. Accurately Completes documentation related to the Gelatin process. Measures and weighs, by manual and computerized scales, gelatin and dyes used in gelatin batches. Processes gelatin master batches and color conversion per applicable SOP and batch record instructions.

Performs major and minor changeovers of equipment and rooms efficiently in timely manner, along with filling out proper documentation on batch records and maintaining good documentation practices. Gets clearance from QA on appropriate equipment and GMP rooms for processing. Operates production equipment as required per applicable SOP.

Washes, inspects, and sanitizes gelatin receivers and equipment. Performs work according to safety policies and practices related to the position. Maintains a clean work area. Notifies Supervision immediately if there is any deviation from the batch record, SOP, or potential production event. Cross - training in performing tasks, operate equipment and maintaining the necessary documentation in other production departments may be required.

Depending on shift staffing level and/or the workload, an operator could be assigned to perform tasks in areas different than her/his primary position/business unit Education and Experience High school diploma or GED (General Educations Diploma). 2+ years of experience; or equivalent combination of education and experience.

Able to read and follow SOP’s. Able to work in compliance of current GMPs. Able to perform basic math calculations (add, subtract, multiply, divide). Able to perform weighing. Able to follow written and verbal instructions. Knowledge, Skills and Abilities Understanding of SOP’s. Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over head, face, hands, and arms.

Work efficiently. Weighing. Operates equipment. Cleans and inspects equipment. Ability to push or pull 500kg gel tanks. Maintains neat and organized work area. Cross training in other departments and tasks. Must execute good documentation practices. Executes good trouble shooting skills. Physical/Work Environment/Expectations This position works within a GMP Manufacturing Environment, office environment, and inside the plant Must be able to work in controlled environments requiring special gowning Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over the head, face, hands, and arms No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments Pace may be fast and job completion demands may be high While performing the duties the employee is frequently required to sit, stand, walk, and reach with hands and arms; stoop, kneel, crouch or crawl; and see, talk, and hear.

The employee must occasionally lift or move up to 50 pounds. Specific vision abilities required by this job include close vision Note: This job description is not totally inclusive, nor it is designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.