QA Inspector I - DPI

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


QA Inspector I - DPI


Organization Name


InvaGen Pharmaceuticals, Inc.


Location


7 Oser Avenue,


Hauppauge, NY


Shift


Second Shift (3:00PM - 11:30PM)


Employment Type


Full Time


Salary Range(Base/salary)


$16.64 - $22.88


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, paid family leave, employee discounts, and other benefits.


Overview


The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing and packaging in compliance with established procedures


Responsibilities/ Accountabilities

• 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


Minimum Science Graduate


Experience

Minimum 1-2 years' experience in pharmaceuticals (DPI, MDI or Injectables preferred).


Skills/ Competencies

• Knowledge of Good Manufacturing Practices and 21 CFR Part 820.
• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organization skills with the ability to focus on details
• Basic computer skills (Microsoft Word, Power and Excel).

GLOBAL COMPANY


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.


Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare.The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future.Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)


About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement


Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.