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 SOPs.
  • 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 note supported in this position.