American Regent, Inc.
QA Inspector (7am-3:30pm) page is loaded## QA Inspector (7am-3:30pm)locations:
Shirley, NYtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-102969**Nature and Scope**This position is responsible for providing Quality oversight in manufacturing areas including, but not limited to Formulation, Filling, Inspection, Equipment Prep and Packaging through the execution of site policies and procedures, programs, and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. The QA Inspector maintains compliance with quality programs.**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.* 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.* 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, 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.**Physical Environment and Requirements*** 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.
PPE and Respirators are essential for the health and safety of employees.* Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.## **Expected Hourly Rate:**## **$23.61-$25.00**## The hourly rate displayed is the 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:* Know Your Rights: )* Employee Polygraph Protection Act:**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
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.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 Pennsylvania and sales territories nationwide. #J-18808-Ljbffr
Shirley, NYtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-102969**Nature and Scope**This position is responsible for providing Quality oversight in manufacturing areas including, but not limited to Formulation, Filling, Inspection, Equipment Prep and Packaging through the execution of site policies and procedures, programs, and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. The QA Inspector maintains compliance with quality programs.**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.* 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.* 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, 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.**Physical Environment and Requirements*** 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.
PPE and Respirators are essential for the health and safety of employees.* Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.## **Expected Hourly Rate:**## **$23.61-$25.00**## The hourly rate displayed is the 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:* Know Your Rights: )* Employee Polygraph Protection Act:**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
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.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 Pennsylvania and sales territories nationwide. #J-18808-Ljbffr