Job Description
Job Description
JOB SUMMARY
IPQA Associate is to perform all required in- process testing & sampling for Manufacturing and Packaging batches, Perform incoming inspections raw materials, dispensing of raw materials, Approvals & line Clearances for Manufacturing, Packaging who should be ready to work in 2nd & 3rd shifts.
- Perform line clearances of the manufacturing/ packaging areas and equipment
- Performing Cleaning Verification/Validation Swabbing of Equipment
- Capture critical information for Deviation investigations/ CAPA (when necessary)
- Collection and inventorying of Retain and/ or Stability Samples
- Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)
QUALIFICATIONS
- HS Diploma
- Experienced in proper documentation and correction practices
- Read, write and speak English
MANDATORY
- 2-3 year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
- A familiarity with cGMPS, CFRs, OSHA and FDA regulations
- Experience with deviations /incidents and CAPA
- Should be able to work long hours to support production requirements
- Should be available for overtime, including weekends, as needed for production support
- Recuritment is for 2nd and 3rd shifts only.
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- Stand/walk for the majority of the shift.
- Must be able to bend at the waist and knees as well as twist at the trunk.
- Must practice good personal hygiene