IPQA Associate


Job ID 17-00157

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

Want to work for a top Generic Pharma company with lots of growth potential? How about a company that you can be promoted quickly and be recognized for your work? We have a direct relationship with our Hiring Managers and can get you in for the interview! This client provides great benefits and bonus structure as well. Apply with us today!

 

JOB SUMMARY
IPQA Associate is to perform all required in- process testing & sampling for Manufacturing and Packaging batches. Perform incoming inspections and outgoing inspections of finished product batches. Perform verifications using special instruments (Caliper, Balance, etc.) to assign final Approval to Labeling, Packaging and Raw Materials.
REPORTING RELATIONSHIPS
This position reports to the QA Supervisor or QA Manager
PERCENT OF TIME - FREQUENCY - ESSENTIAL DUTIES
85 %
Daily
- Perform all required in-process testing & sampling of batches in progress and products to be packaged.
- Perform line clearances of the manufacturing/ packaging areas and equipment
- Verify and confirm issuances and reconciliation of product and components.
- Performing Cleaning Verification/Validation Swabbing of Equipment
- Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working condition
5%
Weekly
- Handle various requests from departments for developmental or investigative reasons
- Capture critical information for Customer Complaint/Deviation investigations/ CAPA (when necessary)
- Review and Approve Preventive Maintenance or Work Orders; (if necessary)
- Participate in Stability/Validation product Sampling
10%
Monthly
- Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves.
- Complete all applicable training forms in a timely manner and forward to document control for archival
- Data Entry of Finished Product Information into the APR (Annual Product Review ) system
OTHER FUNCTIONS AND RESPONSIBILITIES
- 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)
- Replace Temperature/Humidity Charts weekly
- Maintaining IPQA supply inventory



Qualifications

QUALIFICATIONS
- HS Diploma
- Experienced in proper documentation and correction practices
- Read, write and speak English
REQUIRED
- 2-3 year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
- Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals
- Be able to work long hours to support production requirements
- Be available for overtime, including weekends, as needed for production support
- Possess the ability to analyze information and make consistently good decisions
ANY REQUIRED LICENSES/CERTIFICATIONS
A familiarity with cGMPS, CFRs, OSHA and FDA regulations
Experience with deviations /incidents and CAPA