Compounder

Harrow, Inc.•Roxbury Township, NJ

1d•Onsite

About The Position

HOURS - 3:00PM - 1:30AM 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, under ISO7 and ISO5 area, 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, performing filling operations under ISO7 environment.

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 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.

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 documentations. 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