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American Regent, Inc. · 18 hours ago

QA Inspector (3pm-11:30pm)

Shirley, NY

Full-time

Onsite

Entry Level

$23.61/hr - $25/hr

1+ years exp

American Regent, Inc. is a company focused on providing quality oversight in manufacturing areas. The QA Inspector role is responsible for ensuring that all processes and products meet specifications and comply with cGMP requirements, conducting inspections, and maintaining quality programs.

Health CareMedical

H1B Sponsor Likely

Responsibilities

All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134) Drug product inspection

Achieve and maintain Aseptic Processing Area (APA) gown qualification

Adhere to all SOP related to working in an aseptic environment, including volume/weight checks of product filled in vials and ampoules; s well as the monitoring of personnel Aseptic Technique

Checks product lot number information, documents in the batch record where applicable, and reviews Master Batch Records for accuracy at all stages in the manufacturing process - Formulation, Filling, Inspection, and Packaging

Conducts product in-process inspections at designated intervals

Determines the Acceptable Quality Limits (AQL) by using the (American Nation Standards Institute) ANSI Z1.4 Standard Inspectors Rule, the ruler assists with the calculation of sample size and Accept/Reject (A/R) numbers

Conducts inspection of formulation equipment (e.g. tanks) for cleanliness, imperfections, and acceptable operating condition

Documents verification of task performed (where applicable)

Conducts visual inspection of filled vials and ampoules after manual or automated inspection for defined critical major and minor defects, as well as particulate matter

Conducts inspection of printed materials (e.g. labels), inserts, finished units, unit packs, and shipping containers for critical major and minor defects

Perform monthly inspection of the retentions samples to ensure quality of finished products until expiration

Assist in the management of the sample retention room (removing samples for monthly inspections, putting away samples from monthly inspections, adding new samples to the room, and removing samples from the room that have expired)

Reports all non-conformances to supervision

Qualification

Quality AssuranceCGMP complianceAseptic TechniqueMathematical calculationsMicrosoft OfficeSterile gowningStandard English readingAttention to detail

Required

High School Diploma or GED equivalent, required

1 year of related experience in Quality Assurance and/or manufacturing within a cGMP environment, preferred

Experience in a pharmaceutical, biotech, food, or related manufacturing environment, preferred

Working knowledge of good manufacturing systems, familiarity with regulatory and manufacturing SOPs and cGMPs, preferred

Ability to perform accurate mathematical calculations, required

Basic computer skills including Microsoft Outlook, Word, Excel, required

Strong attention to detail, adherence to SOPs, and a desire for ensuring a high-quality product

Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals

Ability to meet and maintain sterile gowning requirements

Ability to work overtime as needed, including weekends when required

Employee must be able to occasionally lift and/or move up to 25 pounds

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision

Preferred

1 year of related experience in Quality Assurance and/or manufacturing within a cGMP environment, preferred

Experience in a pharmaceutical, biotech, food, or related manufacturing environment, preferred

Working knowledge of good manufacturing systems, familiarity with regulatory and manufacturing SOPs and cGMPs, preferred

Benefits

Healthcare

Life insurance

Profit sharing

Paid time off

Matching 401k

A wide range of other benefits

Company

American Regent, Inc.

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.

Founded in 1967

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

H1B Sponsorship

American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (6)

2024 (10)

2023 (4)

2022 (5)

2021 (8)

2020 (9)