COMPOUNDER General Description: Compounder II is responsible for executing compounding schedules set by Compounding Supervisor.
To accomplish this objective, Compounding II must train new employees in the manner required by management.
Must be proficient in all compounding 1 areas and have knowledge of Sanitizing and utility responsibilities.
Develops and demonstrates troubleshooting skills, how to communicate issues, and provide suggestions for improvement.
Specific Responsibilities & Duties: Promotes a safe working environment and adheres to Health, Safety, and Environmental procedures, company safety rules, Current Good Manufacturing Practices (CGMP’s), Standard Operating Procedures (SOP’s) in line with the company’s objectives and policies at all times with everyone in the department.
No short cuts allowed Reviews compounding schedules set by Compounding Management.
Communicates with pre-weigh, QC, R& D, and customers regarding compounding of batches.
Performs all compounder II duties with proficiency.
Provides on the job departmental training to new employees.
Ensures equipment and tanks are assigned and prioritized to carry out the daily assignments.
Communicate any issues to the supervisor.
Learns to perform batch calculations as needed for customer products.
Works with quality to get samples and adjustments.
Works with maintenance to maintain department equipment.
Attends compounding scheduling meetings to provide product status and availability information.
Performs IQ/OQ as needed with validation department Works on customer batches, pilot, and 1st production validations.
Supplies feedback during the process.
Troubleshoots equipment and reports to supervisor when issues arise.
Performs supply inventory checks and informs supervisor of status.
Leads special activities as assigned (i.E.
inventory, calibrations, etc.).
Follows up on accuracy and completeness of job assignments by completing the monthly checklist Verifies paperwork on work orders is accurate and complete before taking it to the lab.
Enforce safety (i.E.
Safety equipment, Safety practices).
Enforce SOP’s, GMP’s, and SP’s.
Reviews production schedules to ensure the product will be ready, as it’s needed.
Other duties may be assigned by Compounding Management.
Job Requirements:Physical Requirements: No allergies or sensitivity to chemicals that may preclude the handling of materials or use of personal protective equipment Wear a respirator when required Climbing stairs of tank area Long periods of standing, walking, bending, stooping, squatting, or kneeling.
Must be capable of handling 55-gallon drums Must be capable of lifting up to 50 pounds.Qualifications: High school education or equivalent.
5 years experience in a Compounding environment; preferably in cosmeticsprocess manufacturing or an FDA-regulated industry.
Excellent understanding of Compounding procedures, practices, and issues based on hands-on experience.
Demonstrated ability to develop and follow up daily schedules.
Previous Pre-Weigh experience Mechanical aptitude to understand the use of Compounding equipment.
Basic knowledge of power and hand tools to perform job functions.
Strong English communications skills: speaking, reading, and writing.
Strong math and analytical skills: addition, subtraction, multiplication, and division Basic PC Knowledge i.E.
MS Office Suite (Excel, Word, Outlook) and MRP Systems is required.
Able to work independently and as a team player Good attendance record.
Must be able to maintain a clean, sanitary, and organized work area.
Maintains housekeeping in conformance, Current Good Manufacturing Practices (CGMP’s), and Standard Operating Procedures (SOP’s).
Self-Management: Display initiative, effort excellent organizational and planning skills, and commitment towards completing assignments in a timely manner.
Teamwork: Build and sustain cooperative working relationships and has strong leadership skills and ability.
Achieving thoroughness and accuracy in completing multiple prioritized projects.
Problem Solving: Identify options for solving a problem and evaluate the strengths and weaknesses.
Good time-management skills Flexibility to work long hours during peak season or special schedules as needed to satisfy job requirements.
Constantly work to improve processes.
Makes suggestions for improvements.
Communicates and collaborates with management.Work Environment: Process manufacturing environment.
Compounding environment.
Wet environment.
Moderate to heavy traffic including forklifts The noise level is moderate.
Lighting is low to moderate