Job Title: CompounderJob DescriptionThe Compounder plays a key role in a process manufacturing environment by safely compounding, mixing, and batching products in accordance with Current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and production schedules. This position coordinates with multiple departments, supports validation activities, and ensures equipment and materials are available and properly used to meet quality, safety, and productivity objectives on a consistent basis.
Responsibilities- Promote a safe working environment at all times and strictly adhere to Health, Safety and Environmental procedures, company safety rules, cGMPs, SOPs, and all related policies within the department.
- Review compounding schedules provided by Compounding Management and organize daily work accordingly.
- Communicate effectively with pre-weigh, Quality Control (QC), Research & Development (R&D), and customers regarding the status and requirements of compounding batches.
- Apply full proficiency in all Compounder 1 requirements and ensure these standards are consistently met.
- Provide basic on-the-job departmental training and guidance to new employees to support their successful onboarding.
- Assign and prioritize equipment and tanks to support daily production assignments, and promptly communicate any issues or constraints to the supervisor.
- Learn and perform batch calculations as needed to support customer products and ensure correct batch sizes and formulations.
- Work closely with the quality team to obtain samples, perform necessary adjustments, and ensure batches meet quality specifications.
- Collaborate with maintenance to support the upkeep and proper functioning of compounding equipment and related systems.
- Attend compounding scheduling meetings to provide accurate product status and availability updates.
- Perform Installation Qualification/Operational Qualification (IQ/OQ) activities as needed in coordination with the validation department.
- Work on customer batches, pilot runs, and first production validations, providing feedback and observations throughout the process.
- Troubleshoot equipment issues during compounding operations and report problems promptly to the supervisor.
- Conduct supply inventory checks, monitor material levels, and inform the supervisor of inventory status and needs.
- Lead special activities as assigned, such as inventory counts, calibrations, and other projects, and complete monthly checklists to verify accuracy and completeness of assignments.
- Verify that all paperwork and documentation on work orders is accurate and complete before submitting materials to the lab.
- Enforce safety practices, including proper use of safety equipment and adherence to safety procedures, and ensure compliance with SOPs, GMPs, and related standards.
- Review production schedules regularly to ensure products will be ready as required and adjust priorities as needed.
- Maintain a clean, sanitary, and organized work area in compliance with cGMPs and SOPs, including housekeeping standards.
- Continuously look for ways to improve compounding processes, make suggestions for improvements, and communicate and collaborate with management on process enhancements.
- Perform other duties as assigned by Compounding Management in support of department and production goals.
Essential Skills- High school education or equivalent.
- 5 years of experience in a compounding environment, preferably in cosmetics process manufacturing or an FDA-regulated industry.
- Strong understanding of compounding procedures, practices, and issues based on hands-on experience.
- Demonstrated ability to develop, organize, and follow up on daily production schedules.
- Previous pre-weigh experience in a manufacturing or compounding setting.
- Mechanical aptitude with the ability to understand and operate compounding equipment.
- Basic knowledge of power and hand tools required to perform job functions.
- Strong English communication skills, including speaking, reading, and writing.
- Strong math and analytical skills, including addition, subtraction, multiplication, and division.
- Basic PC knowledge, including use of MS Office Suite (Excel, Word, Outlook) and MRP systems.
- Ability to work independently with minimal supervision as well as collaboratively as part of a team.
- Consistent and reliable attendance record.
- Ability to maintain a clean, sanitary, and organized work area in compliance with cGMPs and SOPs.
- Strong organizational and planning skills with demonstrated initiative and effort to complete assignments on time