Compounder

Harrowhealth; United States; On-site; USD 48,000 - 64,000; Full time

Job summary

Harrowhealth is seeking a Compounder to perform cGMP manufacturing of sterile dosage forms in ISO7/ISO5 environments. Under supervision, you will set up equipment, weigh materials, manufacture batches, sterilize products, submit samples and perform filling operations in a controlled facility.

You will maintain compliant documentation, review batch records in real time, operate autoclaves, monitor pH, and support continuous improvement in a fast-paced production area.

Qualifications

• High School diploma with 2 years pharma/biotech manufacturing support and 1 year in clean room environments.
• Gowning into aseptic manufacturing areas.
• Excellent organization and time-management; able to handle heavy workload and deadlines.
• Technical knowledge to operate and troubleshoot equipment.
• Fluent in English (written and spoken).

Responsibilities

• Ensure work complies with Safety, GMP and SOPs; follow GXP guidelines.
• Report accidents and hazards; notify manager of unsafe conditions.
• Prepare for production by reviewing schedule, weighing ingredients, and adding to mixing equipment.
• Update knowledge through training; maintain individual training plan.
• Review batch records and logs in real time; ensure error-free documentation.
• Obtain equipment and raw materials for manufacturing.
• Follow batch records and SOPs; perform required tasks.
• Perform batch record review in real time.
• Operate autoclave and monitor pH values.

Skills

Aseptic gowning

Time management

Org. skills

Problem solving

Team player

English fluency

Confidentiality

Education

High School Diploma

Pharma/biotech manufacturing exp.

Clean room training

Tools

Excel

Outlook

Word

Job description

Job Summary

The compounder will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the compounder will work hands‑on in ISO7 and ISO5 areas with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set up, weighing of materials, manufacturing of batches, sterilization of product, submitting samples, and performing filling operations under ISO7 environment.

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Knowledge of current Good Manufacturing Practices (GXP) guidelines.
• Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace.
• Prepares for production run by reviewing the production schedule; identifying batch specific requirements; weighing and measuring ingredients and adding to mixing equipment.
• Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
• Responsible for reviewing all documentation including Batch records and Logbooks in “Real Time and Right First Time” and demonstrating error‑free documentation. Immediately reports any error or deviations noticed to management.
• Obtaining equipment and raw material for manufacturing and compounding.
• Follows all steps outlined in batch records, ability to actively perform all tasks being required by the batch record / SOPs.
• Ability to perform a batch record review in real time.
• Operation of Autoclave.
• Obtaining PH.
• Customer/Client Focus.
• Ethical Conduct; respect for others and solidarity.
• Technical Capacity to operate and troubleshoot processing equipment.
• Conscientiousness for work and documentation.

Qualifications & Requirements

• High School diploma with 2 years – Pharma/Biotech Manufacturing Support and 1 year – within Clean Room environments and some technical certification is desired in a related field.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Excellent organization and time‑management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure.
• Must possess technical knowledge to operate and troubleshoot all operating equipment with minimal help.
• Environmental Monitoring, Water and product sampling.
• Fluent in English both written and spoken.
• Strong work ethic, positive attitude, time management, problem solving, team player, self‑confidence & ability to accept & apply lessons learned as needed. Works with a sense of urgency, while engaging and listening to experts.
• Ability to work in a fast‑paced environment while demonstrating excellent time management and organization skills.
• Strong organizational skills with the proven ability to prioritize.
• Must be dependable and punctual.
• Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word.
• Ability to handle sensitive information with a high degree of confidentiality.
• Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs. Work hours will be subject to change as required based on business demand and production workload.

Position Type

• On‑Site

Travel

• None