What are the responsibilities and job description for the IPQA I position at FORMULATED Solutions LLC?
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.
Salary.com Estimation for IPQA I in Largo, FL
$38,346 to $48,686
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