Material Quality Inspector

American Regent, Inc.; Shirley (NY); On-site; USD 2,901,000 - 3,168,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401k matching

Job summary

American Regent, Inc. in New York is seeking an Inspector to ensure raw materials, primary containers, and packaging components meet established quality standards for manufacturing.

This role performs inspections, sampling, documentation, and contributes to cGMP compliance, SOPs, and monthly metrics, with potential overtime and reading English procedures.

Qualifications

• High school diploma or GED required.
• 2+ years manufacturing experience; pharma or cGMP preferred.
• Proficient in Microsoft Word and Excel.
• Ability to work overtime as needed.

Responsibilities

• Perform inspections for packaging materials and manufacturing support items.
• Perform raw material sampling and related duties, including sample room cleaning and retention sampling.
• Perform finished goods inspection per procedures.
• Process and review documentation for accuracy and cGMP compliance.
• Make noncritical decisions in absence of management per procedures.
• Report cGMP compliance issues to management.
• Assist with creating or revising SOPs and Annual Product Review reports.
• Assist with generating monthly departmental performance metrics.
• Read documents in Standard English (SOPs, maintenance schedules, manuals).
• Perform other tasks as assigned by management.

Skills

Microsoft Word

Microsoft Excel

Reading English documents

Education

High school diploma or GED

2+ years manufacturing experience in pharma or cGMP

Job description

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 also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

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/fml

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

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 [e-mail].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.

American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs.

We have locations in New York, Ohio, and California and sales territories nationwide.