Nature and Scope

This position is a member of the Formulation Team. The Formulation Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs, ensure asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Formulation Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Formulation Process. The Formulation Process includes dispensing, controlling and utilizing chemical raw materials in accordance with batch directions; performing in-process QC sampling and on-site in-process testing of pH, oxygen content, clarity, etc. during batch formulation; cleaning, assembling, sterilizing and collecting QC samples from small and large pieces of equipment in accordance with established production records, includes area cleaning and line clearances of the manufacturing equipment.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Proficient in all activities associated with the compounding process and be able to work with minimal supervision, will receive direction, training, and mentorship from the Senior Compounding Technicians.
• The Team Member will, with assistance from Senior Team Member/s, be able to troubleshoot minor equipment adjustments and repairs during setup and during operation.
• Utilizes scales, balances and load cells to weigh materials and performs batch additions of materials. Utilizes blending, mixing and other homogenization technologies.
• Performs aseptic filtration setup and filter integrity testing and mass/concentration calculations to determine batch dosing in accordance with material potency.
• Stocks, gathers and stages manufacturing supplies and equipment as needed. Gathers, stages and returns production materials as needed.
• Cleans and stores manufacturing equipment and cleans areas as needed.
• Attends all training programs as required by Company SOPs, procedures and policies. Assists in Training new employees on compounding and dispensing raw materials as well as equipment cleaning procedures.
• Is proficient in dispensing raw materials using balances/scales both inside and out of the Formulation Isolator, as well as direct charge into the vessel in accordance with SOPs
• Reviews log books and batch documentation for accuracy during execution on the floor.
• Acts as the Lead in the Lead’s absence.
• Perform any other tasks/duties as assigned by management.

• We all must embrace the QUALITY culture.

Qualifications and Requirements

• High School Diploma or GED equivalent preferred. Associates degree in Chemistry or related science discipline is a plus.

• Minimum 1 year experience as Compounding Technician I having performed at or above a satisfactory level or 3- 5 years work experience in a related field preferred.

• The manufacturing technology utilized at PharmaForce Inc. – New Albany includes HMI-PLC/SCADA controlled Isolation Barrier, Autoclave Sterilization, CIP Sanitization and SIP Sterilization.
• Ability to take feedback constructively and function in a team oriented work environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.

Physical Environment and Physical Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
• Ability to meet and maintain cleanroom gowning requirements.
• Ability to meet and maintain respirator fit-testing requirements.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

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