Compounder Job Elizabeth area,New Jersey USA,Manufacturing / Production

Manufacturing Compo under

Wharton, NJ

Pay rate: $27 - 30+/hr, will consider higher based on experience

Direct-hire!

Hours:

3rd Shift, 11pm to 7am 2nd shift, 3pm to 11pm

Position Summary

The Manufacturing Compo under is responsible for weighing, mixing, and compounding raw materials to produce cosmetic and OTC drug products in accordance with approved formulas, batch records, and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210 and 211. This role ensures accurate execution of manufacturing processes, adherence to specifications, and maintenance of product quality and consistency.

Key Responsibilities:

Weighing & Dispensing
- Accurately weigh and dispense raw materials according to batch records and formulations
- Verify material identity, lot numbers, and quantities prior to use
- Follow proper material handling and labeling procedures
Compounding & Mixing
- Operate mixing and compounding equipment (e.g., tanks, kettles, homogenizers)
- Follow batch instructions for order of addition, mixing times, temperatures, and speeds
- Monitor processes to ensure consistency and quality
Batch Execution
- Execute manufacturing batches in accordance with approved batch records
- Record all required data accurately and in real time
- Ensure compliance with Good Documentation Practices (GDP) and ALCOA+ principles
Equipment Operation & Cleaning
- Set up, operate, and clean compounding equipment
- Perform cleaning procedures in accordance with SOPs and cleaning validation requirements
- Ensure equipment is properly labeled and in appropriate status (clean/dirty/in use)
In-Process Monitoring
- Monitor critical process parameters (temperature, mixing speed, viscosity, etc.)
- Perform in-process checks and sampling as required
- Report any deviations or abnormalities immediately
Compliance & cGMP
- Follow 21 CFR 210/211, cGMP, and company procedures at all times
- Maintain clean and organized work areas in accordance with GMP standards
- Use required PPE and follow safety guidelines
Material & Inventory Control
- Ensure proper handling and storage of raw materials and intermediates
- Assist with material reconciliation and inventory accuracy
- Label and transfer bulk products to the next stage of production
Troubleshooting & Continuous Improvement
- Identify and report process issues or inefficiencies
- Support corrective actions and process improvements
- Assist in scale-up and new product introductions as needed
Cross-Functional Collaboration Work with:
- Quality Assurance (QA) for compliance and documentation review
- Quality Control (QC) for sampling and testing
- Warehouse for material handling and staging
- Support audits (internal, customer, FDA) as required

Qualifications

Experience
- SEEKING MIN 1
  -2 years of experience in manufacturing compounding preferred
- Experience in cosmetic, pharmaceutical, or OTC manufacturing strongly preferred
- Experience in FDA-regulated environments is a plus
Technical Knowledge Basic understanding of:
- cGMP and GDP requirements
- 21 CFR Parts 210 & 211
- Familiarity with mixing, blending, and processing equipment
Skills & Competencies
- Strong attention to detail and accuracy
- Ability to follow detailed instructions and batch records
- Basic math skills (weights, measures, conversions)
- Mechanical aptitude and troubleshooting ability
- Ability to work in a fast-paced environment
Physical Requirements
- Ability to lift up to 50 lbs
- Frequent standing, bending, and lifting
- Ability to work with chemicals and raw materials
- Use of PPE (gloves, goggles, respirators as required)
Work Environment
- Manufacturing and production environment
- Exposure to raw materials, chemicals, and processing equipment
- May require shift work, weekends, or overtime