Material Quality Inspector

americanregent; Shirley (NY); On-site; USD 44,000 - 48,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401k

Job summary

American Regent Inc. is seeking a Quality Control Inspector to ensure raw materials, packaging components and related items meet established quality standards.

You will perform inspections, sampling and testing of materials, inspect finished goods, and review documentation for accuracy and compliance with cGMP. Reading SOPs in English and assisting with SOP updates are part of the role.

Qualifications

• 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.

Responsibilities

• Inspect packaging materials and manufacturing support items.
• Perform raw material sampling including inspection and testing.
• Inspect finished goods per procedures and documentation.
• Process and review documentation for accuracy and compliance.
• Read SOPs and schedules in Standard English.
• Assist with SOP/Annual Product Review updates.
• Generate monthly departmental performance metrics.
• Perform other duties as assigned by management.

Education

High school diploma or GED

Tools

Microsoft Word

Microsoft Excel

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

The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

• 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/fmlan.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

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] .