Compounding Operator

POSITION SUMMARY

The Soft gel Compounding Operator is responsible for making good batches of fill materials and gelatin solution.  Follows written procedures in the form of batch records. Responsible for the safe operation of all compounding equipment and work areas. Ensures compliance with standard operating procedures, safety rules and current good manufacturing practices. 

ESSENTIAL FUNCTIONS 

Reasonable Accommodations Statement

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. 

Essential Function Statement(s)

• Required to competently operate soft gel compounding equipment independently
• Assure applicable SOPs are followed and production is performed in accordance with cGMPs
• Provide “hands on” training to new encapsulation employees
• Document activities in logbooks incorporating good documentation practices
• Disassemble and clean compounding machines and equipment
• Assemble and set up compounding machines and equipment
• Clean working area and raw material/gelatin tanks
• Adhere to batch record specifications and keep the compounding process in control
• Perform compounding Start Up Activities and fill material mixing
• Document in process checks in the Production Batch Record following GOOD Documentation Practices (GDPs)
• Check machines and equipment for proper tag status (Ex.  To be Cleaned, Operating Tag, Ready to use, etc.)
• Control loss and waste of materials
• Ensure transfer bottles or spray bottles are properly labeled
• Wear the required personal protective equipment
• Adhere to gowning procedures
• Operate equipment in a safe manner
• Notify management of abnormal activities
• Assure MFG, equipment is in proper working order and initiate maintenance work orders when necessary with Lead, Shift Supervisor
• Performs other duties as assigned.

POSITION QUALIFICATIONS 

Competency Statement(s) 

• Positive – Ability to view all situations with a positive attitude. 
• Innovative – Ability to look beyond the standard solutions and “think outside the box”.
• Detail Oriented – Ability to pay attention to the minute details of a project or task.
• Enthusiastic – Ability to bring energy to the performance of a task.
• Friendly – Ability to exhibit a cheerful demeanor toward others.
• Initiative – Ability to make decisions or take actions to solve a problem or reach a goal.
• Organized – Possessing the trait of being organized or following a systematic method of performing a task.
• Reliability – The trait of being dependable and trustworthy.

SKILLS & ABILITIES 

Education: 

• Minimum High School Diploma or equivalent.
   

Experience: 

• 1–2 years of experience in a manufacturing environment.
• Experience mixing raw materials in accordance with batch records, formulations, and production schedules preferred.
• Experience operating and monitoring high-pressure production equipment preferred.
• Previous experience working with softgel encapsulation equipment preferred.
• Must be mechanically inclined with the ability to troubleshoot and adjust equipment as needed.

Computer Skills: 

• N/A

PHYSICAL DEMANDS

Physical Demands	Lift/Carry
Stand  O (Occasionally)  Walk  O (Occasionally)  Sit  F (Frequently)  Handling / Fingering  F (Frequently)  Reach Outward  O (Occasionally)  Reach Above Shoulder  O (Occasionally)  Climb  O (Occasionally)  Crawl  N (Not Applicable)  Squat or Kneel  O (Occasionally)  Bend  O (Occasionally)	10 lbs or less  O (Occasionally)  11-20 lbs  O (Occasionally)  21-50 lbs  O (Occasionally)  51-100 lbs  O (Occasionally)  Over 100 lbs  N (Not Applicable)
Push/Pull
12 lbs or less  O (Occasionally)  13-25 lbs  O (Occasionally)  26-40 lbs  O (Occasionally) 41-100 lbs  O (Occasionally)

N (Not Applicable)	Activity is not applicable to this occupation.
O (Occasionally)	Occupation requires this activity up to 33% of the time (0 - 2.5+ hrs/day)
F (Frequently)	Occupation requires this activity from 33% - 66% of the time (2.5 - 5.5+ hrs/day)
C (Constantly)	Occupation requires this activity more than 66% of the time (5.5+ hrs/day)

Other Physical Requirements 

• Vision (Near, Distance) 

WORK ENVIRONMENT 

• Works in a climate-controlled environment.