QA Inspector II - 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

DPI QA Inspector II

Organization Name

Inva Gen Pharmaceuticals, Inc.

Location

Employment Type

Full Time

Shift

Third Shift: 11:00 PM – 7:30 AM (May vary based on business needs)

Salary Range
(Base/salary)

$24/hr - $31/hr

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, elevate 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.
• 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,…