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About the Role
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.
Responsibilities
- 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.
- Perform blend uniformity (BU) sampling.
- 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.
- Perform posting of dispensed materials and samples into SAP system (ERP system) and 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).
- Take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.
- Report and escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
- Perform other duties that management may assign from time to time.
Requirements
- 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.
- 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.
- 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.
Skills
- 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.
Location
- Unit 1 – 7 Oser Avenue, Hauppauge, NY 11788
Work Type
- Full Time
- Third Shift: 11:00 PM – 7:30 AM (May vary based on business needs)
Experience Level
- 1-2 years of pharmaceutical experience
Education Level
- Science Graduate
Salary/Compensations
- $24/hr - $31/hr
Benefits
- 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
- Other benefits
About the Company
- Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines.
- 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.
- The company was founded in 2003 and is based in Central Islip and Hauppauge, New York.
- In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.
Equal Opportunity
- 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.