Nature and Scope
Responsible for ensuring that raw materials, primary containers and packaging components used in the manufacture of products for American Regent Inc. meet the established standards of quality.
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.
Perform Inspections for Packaging Materials and Manufacturing support items including inspection, dimensional verification, functional and chemical testing.
Perform Raw Material sampling including inspection, sampling of non-hazardous and hazardous raw material, cleaning of raw material sample rooms, use of electrical balance and retention sampling.
Perform Finished Goods inspection in accordance with appropriate procedures the inspection of finished goods.
Process and/or review documentation for accuracy and compliance to Good Documentation Practices.
Make noncritical decisions in the absence of management based on procedures and processes.
Report any cGMP compliance issues to the management team.
Assist with the creation or revision of Standard Operation Procedure’s and Annual Product Review reports.
Assist with generating monthly departmental performance metrics.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
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 required.
2+ years’ experience in manufacturing; pharmaceutical manufacturing or a cGMP environment, preferred.
Proficient in Microsoft Word and Excel.
Ability to work overtime as needed.
Physical Environment and 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.
Employee must be able to occasionally lift and/or move up to 50 pounds.
Must have 20/20 vision, corrected if necessary.
Must successfully pass Color Blindness Screening (D15).
Expected Hourly Rate:
$21.06-$23.00
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 jrossini@americanregent.com 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 hrtalentacquisition@americanregent.com
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
American Regent continues to position its business for sustainable growth, with significant investments in the modernization and expansion of our U.S. manufacturing sites. These enhancements are expected to strengthen our business and represents our commitment to the ongoing success of our company and its employees.
Supporting patient health is our guiding principle and our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of brand and generic specialty injectables.
