Description
\t\t\t\t\tKey Responsibilities:1. Hands-On Weigh-Up and Compounding Activities• Accurately weigh and measure raw materials following approved batch records and formulations.• Perform compounding operations, ensuring proper mixing, blending, heating, and emulsification based on product specifications.• Maintain control of pH, viscosity, and other key product parameters during compounding.• Ensure proper handling and storage of raw materials, APIs, and chemicals per regulatory requirements.• Follow First-In-First-Out (FIFO) for components and First-In-First-Expire (FIFE) for chemicals to ensure product integrity.2. Supervision & Team Leadership• Lead and oversee the weigh-up and compounding team, ensuring accuracy, efficiency, and compliance with GMP.• Train and mentor team members on proper weighing, compounding, documentation, and safety practices.• Assign daily tasks and monitor progress to ensure production deadlines are met.• Enforce adherence to company policies, safety regulations, and cleanliness standards.• Provide feedback to employees, identify skill gaps, and recommend training opportunities.3. Compliance with FDA Regulations, GMP & SOPs• Ensure all activities align with FDA 21 CFR 210 and 211, OTC monograph requirements, and GMP standards.• Follow and enforce Standard Operating Procedures (SOPs) for weigh-up and compounding.• Maintain compliance with Good Documentation Practices (GDP), ensuring all records are accurate and complete.• Support internal and external audits by providing necessary documentation and explanations.4. Equipment Operation & Maintenance• Operate compounding equipment, including mixers, kettles, pumps, and filtration systems.• Perform pre-operation checks to confirm equipment readiness and cleanliness.• Ensure proper calibration and maintenance of scales, pH meters, and other lab instruments.• Report any equipment malfunctions or deviations to management for corrective action.5. Batch Record Documentation & Quality Assurance• Complete and verify all documentation, including BMRs, logs, and deviation reports, in real-time.• Work closely with Quality Assurance (QA) to ensure compliance with product specifications and release requirements.• Investigate and resolve any discrepancies in weigh-up or compounding processes.• Support root cause analysis and corrective actions for non-conformances.6. Warehouse & Inventory Coordination• Coordinate with warehouse personnel to ensure timely delivery of raw materials.• Verify the integrity and identity of raw materials received, ensuring COA and SDS are available.• Ensure that all weighed materials are labeled correctly and stored in the appropriate status (quarantine, approved, hold, or reject).• Maintain accurate usage records and report material shortages or excesses to management.7. Workplace Safety & Cleanliness• Enforce strict adherence to safety protocols, including PPE usage and chemical handling procedures.• Conduct routine inspections of the weigh-up and compounding areas to ensure compliance with cleanliness and organization standards.• Monitor and report any potential safety hazards or risks in the workplace.• Ensure compounding rooms, weighing areas, and equipment are properly cleaned and sanitized according to SOPs.
\t\t\t\t\tSkills
\t\t\t\t\tCompounding, Blending, documentation review, quality assurance, batch record, gmp, Fda
\t\t\t\t\tTop Skills Details
\t\t\t\t\tCompounding,Blending,documentation review,quality assurance,batch record,gmp,Fda
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t• High school diploma or equivalent required; associate degree or technical certification in chemistry, pharmaceutical science, or manufacturing preferred.• Minimum 3+ years of experience in compounding or weigh-up operations within an FDA-regulated OTC, pharmaceutical, or cosmetic manufacturing environment.• Prior experience in a supervisory or team lead role preferred.• Strong understanding of FDA 21 CFR 210 & 211, GMP, and GDP requirements.• Experience working with batch manufacturing records (BMRs), SOPs, and safety data sheets (SDS).• Ability to operate and troubleshoot compounding equipment.• Strong organizational, communication, and leadership skills.• Ability to lift up to 50 lbs and work in a physically demanding environment.
\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
Pay and Benefits
The pay range for this position is $25.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Holly Hill,FL.
Application Deadline
This position is anticipated to close on Mar 25, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.