Quality Assurance Inspector II - DPI
Responsibilities
- The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specification
- 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.
- 1-2 years of experience (DPI, MDI or Injectables) preferred
- High School Diploma or educational equivalent with strong science exposure (required)
- 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.
- 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.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.