Nature and Scope
This entry level position is a member of the Formulation Team, who comprise a portion of the Manufacturing Team. This position will be expected to execute the required responsibilities and tasks necessary to perform as a Compounder I using current Good Manufacturing Practices (cGMP) according to approved SOPs in order to support the overall mission of the Manufacturing Team.
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.
Collect and weigh up residual bulk.
Clean formulation equipment including but not limited to: bulk tanks and supply lines.
Disassemble, clean, and prepare filters.
Calibrate scales and pH meters as per SOPs.
Clean Formulation work areas.
Sample water system within the Formulation areas.
Performs all duties in accordance with current effective SOPs.
Records accurate data into logbooks and batch records while maintaining data integrity.
Must maintain cleanliness within the compounding areas.
Responsible for accurate manufacturing and product quality as states in the process description.
Integrates the activities of the Formulation department with Maintenance Engineering, Validation, Filling, Micro laboratory and QC laboratory departments.
Takes steps to assure scheduling problems do not develop by coordinating directly with the Lead Compounder, Formulation Supervisor and Production Supervisors.
Stops production whenever efficiency, quality, or safety is judged to be unsatisfactory.
Performs other related duties as requested by the Formulation Lead Compounder and Manufacturing Supervisor.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
High School Diploma or GED equivalent preferred.
Ability to lift up to 50 pounds frequently.
Ability to work independently.
Ability to work overtime as needed.
Ability to work in an environment where chemicals are handled and dispensed daily.
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 Requirements
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Must be able to stand for prolonged periods of time while fulfilling job duties.
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.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
· Our recruiting process includes multiple in person and/or video interviews and assessments.
· If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
· We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ 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 [email protected].
Skills Required
- High School Diploma or GED equivalent
- Ability to lift up to 50 pounds frequently
- Ability to work independently
- Ability to work overtime as needed
- Ability to work in an environment where chemicals are handled and dispensed daily
- Ability to take feedback constructively and function in a team-oriented environment
- Able to read documents in Standard English (SOPs, maintenance schedules, manuals)
- Maintain clean-shaven appearance to wear tight-fitting respirators properly
- Must be able to stand for prolonged periods
What We Do
American Regent, Inc., a Daiichi Sankyo Group Company, is a leading manufacturer of generic and branded specialty sterile injectable products. Dedicated to improving human and animal health, the company develops, manufactures, and supplies high-quality injectables for healthcare providers, clinics, and hospitals across the United States and Canada. Their expansive portfolio includes a strong focus on IV iron therapy and other critical specialty injectable medications.
