Department: Azzur Solutions, LLC
The compounding operator will work closely with other production personnel in classified clean rooms to compound and process sterile bulk product for filling operations. Batch production records and SOPs will be followed to perform related duties. The duties include but will not be limited to:
Works closely with other departments to ensure that batch production is completed in a safe, compliant, and timely manner.
Wears proper personal protective equipment and follows aseptic procedures when gowning, degowning and working in the sterile and controlled areas.
Preparation of cleaning solutions
Cleaning of compounding/processing rooms and other critical surrounding areas
Cleaning and sterilization of ancillary equipment
Cleaning and setting up of production compounding and processing equipment
Prepares equipment by performing cleaning-in-place (CIP), steam-in-place (SIP), and cleaning out-of-place (COP) procedures. Completes all necessary cleaning and preventative maintenance checks including filter integrity testing. Staging of raw materials per batch record pick list.
Prepares for production run by reviewing the production schedule; identifying batch specific requirements; weighing and measuring ingredients and adding to mixing equipment.
Operates and monitors batching equipment; observing and recording varying conditions; adjusting equipment and controls; conducting dilutions and yield calculations and following all relevant procedures.
Adheres to production schedules and ensures that all tasks are performed in a timely manner
Completes all related bath production documentation Troubleshoots basic production related issues such as raw material discrepancies, equipment problems, etc.
Documents all activities as they occur in log books and Production dockets as required. Maintains cleaning logs per SOP requirements.
Aids management for investigations or studies
Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
Assists with the training of new operators as required.
High school diploma GED or College Diploma in Sciences or BSc Experience: 4-6 years
Must be able to perform calculations using simple mathematical formulas using fractions, percentages and significant numbers.
Experience in basic formulation calculations (net weight calculations, potency, yields, etc.)
Good command of the English Language. Must be able to read, understand, follow and comply with technical and written documents and processing instructions as well as clearly and accurately document all required information into batch documents.
Mechanical aptitude required in order to operate pumps, scales, PLC’s and PH meters.
Must be able to work around chemicals such as acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
Classified clean room and gowning experience.
Manufacturing experience in a GMP environment. Pharmaceutical production experience is highly preferred.
Physical requirements include stooping, bending, standing, climbing and lifting of between 20 kg – 30kg. Must be able to work while wearing full protective gowning for entire shift.
Autoclaving experience – such as wrapping items using autoclaving material. Packaging experience – such as doing needed paper work for labels, inserts and boxes.
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!