Cipla USA
NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.
Job Title: DPI QA Inspector II
Organization Name: InvaGen Pharmaceuticals, Inc.
Location: Unit 1 - 7 Oser Avenue, Hauppauge, NY 11788
Employment Type: Full Time
Shift: First Shift: 8:30 AM - 5:00 PM
(May vary based on business needs) Salary Range (Base/salary): $18.72/hr - $26/hr Benefits:
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, employee discounts, and other benefits. Responsibilities/ Accountabilities
The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications. Verification of raw materials during the dispensing process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, to perform blend uniformity (BU) sampling. To clean and maintain the samplings rods/dies/sample boxes used for BU sampling. Perform IPQA testing on the manufacturing floor specifically LOD, Bulk Density, Tapped Density, Leak Test, Weight Variation test. Ensure cleaning of manufacturing and packaging equipment, area and provide line clearance. To perform posting of dispensed materials and samples into SAP system (ERP system) and to perform other transactions in SAP. Involve in investigation of Deviation, OOS, OOT, or any other non-conformances. Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Review of engineering records (temperature and humidity data, calibration reports and PMP records). To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. Other duties (additional support) that management may assign from time to time. Education Qualifications/Experience
Minimum Science Graduate A minimum of 1-2 years of pharmaceutical experience (DPI, MDI or Injectables) preferred. Preference will be given to candidates with experience in generic pharmaceutical manufacturing. Skills/ Competencies
Knowledge of Good Manufacturing Practices and 21 CFR Part 820. Ability to read, write and communicate effectively. Basic computer skills (Microsoft Word, Power and Excel). Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously. Excellent organization skills with strong attention to details skills. Strong fundamental mathematical skills and knowledge. Physical Requirements
Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 35 lbs., may be required. Able to wear appropriate personal protective equipment at all times, when required. Other Information
This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility is required. Remote work and relocation are not supported in this position. About Cipla
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.
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(May vary based on business needs) Salary Range (Base/salary): $18.72/hr - $26/hr Benefits:
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, employee discounts, and other benefits. Responsibilities/ Accountabilities
The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications. Verification of raw materials during the dispensing process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, to perform blend uniformity (BU) sampling. To clean and maintain the samplings rods/dies/sample boxes used for BU sampling. Perform IPQA testing on the manufacturing floor specifically LOD, Bulk Density, Tapped Density, Leak Test, Weight Variation test. Ensure cleaning of manufacturing and packaging equipment, area and provide line clearance. To perform posting of dispensed materials and samples into SAP system (ERP system) and to perform other transactions in SAP. Involve in investigation of Deviation, OOS, OOT, or any other non-conformances. Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Review of engineering records (temperature and humidity data, calibration reports and PMP records). To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. Other duties (additional support) that management may assign from time to time. Education Qualifications/Experience
Minimum Science Graduate A minimum of 1-2 years of pharmaceutical experience (DPI, MDI or Injectables) preferred. Preference will be given to candidates with experience in generic pharmaceutical manufacturing. Skills/ Competencies
Knowledge of Good Manufacturing Practices and 21 CFR Part 820. Ability to read, write and communicate effectively. Basic computer skills (Microsoft Word, Power and Excel). Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously. Excellent organization skills with strong attention to details skills. Strong fundamental mathematical skills and knowledge. Physical Requirements
Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 35 lbs., may be required. Able to wear appropriate personal protective equipment at all times, when required. Other Information
This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility is required. Remote work and relocation are not supported in this position. About Cipla
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.
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