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Job Description
As posted by the hiring company
Job Overview:
PRIMARY PURPOSE:
The In-Process Quality Assurance (IPQA) I serves as the Quality representative on the manufacturing floor, ensuring products are manufactured in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, internal procedures, and quality standards. This role provides quality oversight during production operations, conducts inspections and audits, assists with troubleshooting, and partners with Production to ensure consistent product quality and regulatory compliance.
MAJOR DUTIES AND RESPONSIBILITIES:
- Adherence to all company procedures/SOPs (Standard Operating Procedures)
- Demonstrate Good Documentation Practices (GDP)/Good Manufacturing Practices (cGMP) daily
- Perform finished product inspections on all the products using measuring gauges (calipers, crimp gauges, pressure gauges, etc.); scales; visual inspection
- Perform review of in-process checks
- Verify pre and post clearance activities during production runs.
- Perform daily verification of instrumentation (scales, gauges, etc.)
- Perform monitoring and verification of monthly logbooks (temperature, pressure differential, equipment logs, etc.)
- Accurately review and record data.
- Accurately collect retain samples and samples for Analytical and Micro Lab
- Perform audits of the batch records
- Acts as a liaison between Quality and Production
- Demonstrate proficiency in quality finished product inspections on at least 75% of different production machine lines
- Provide support to all other departments with an overall quality capacity when needed (lab, warehouse, etc.)
- Promote continuous improvement and customer satisfaction
- Participate in other activities as required by Quality Management
- Conduct scheduled monthly GMP Area Audits
- Perform MIPT test for Aerosol and BOV products
- Perform In-Process inspections as outlined in SOP
- Perform Level II Inspections as outlined in Protocols
- Assist with training with operation personnel (avoid past due training)
- Assist with obtaining NOE information
- Assist with Deviation Investigation data/information gathering
- Assist operations with Rework Protocols
- Assist with operations training avoid past due training
- Assist with modifying site procedures
- Novice level in MIPT lab activities
QUALIFICATIONS:
- Working knowledge of FDA regulations for drugs and/or medical devices.
- Knowledge of inspecting critical parameters for the following products: aerosols, tubes, liquids
- High School diploma or equivalent.
CRITICAL SKILLS AND ABILITIES:
- Ability to use a personal computer and measuring devices.
- Attentive to detail, thorough and accurate
- Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
- Ability to perform effectively under conditions of fluctuating workload.
- Ability to handle and resolve recurring problems.
- Communicate with others clearly and concisely.
- Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
