Overview
IPQA II Jobs in Largo, FL at FORMULATED Solutions LLC
PRIMARY PURPOSE:
The In-Process Quality Assurance (IPQA) II is responsible for ensuring products are manufactured in compliance with current Good Manufacturing Practices (cGMP), company Standard Operating Procedures (SOPs), and applicable regulatory requirements. This role performs in-process and finished product inspections, audits manufacturing documentation, verifies production activities, and serves as a quality resource to Production and other departments. The IPQA II also supports training initiatives and helps drive continuous improvement while maintaining the highest standards of product quality and customer satisfaction.
MAJOR DUTIES AND RESPONSIBILITIES:
- Adhere to all company policies, procedures, and Standard Operating Procedures (SOPs).
- Demonstrate and maintain compliance with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
- Perform finished product inspections using measuring equipment including calipers, crimp gauges, pressure gauges, scales, and visual inspection techniques.
- Review and verify in-process quality checks throughout manufacturing.
- Verify pre-production and post-production line clearance activities.
- Perform daily verification and calibration checks of quality instrumentation, including scales and gauges.
- Monitor and verify monthly logbooks, including temperature, pressure differential, equipment, and related records.
- Accurately review, record, and maintain quality documentation.
- Collect and manage retain samples and samples for Analytical and Microbiology Laboratories.
- Audit batch production records to ensure accuracy, completeness, and compliance.
- Serve as a liaison between the Quality and Production departments to resolve quality-related issues.
- Assist with the training and development of IPQA Inspector I team members.
- Train and support Line Leaders and Production Assemblers on in-process inspection requirements and quality procedures.
- Demonstrate proficiency performing quality inspections across all production machine lines.
- Provide quality support to other departments, including Laboratory, Warehouse, Engineering, and Operations, as needed.
- Promote continuous improvement initiatives and support customer satisfaction objectives.
- Participate in additional quality assurance activities and special projects as assigned by Quality Management.
QUALIFICATIONS:
- High School diploma or equivalent required.
- Working knowledge of FDA regulations applicable to pharmaceutical and/or medical device manufacturing.
- Knowledge of quality inspection requirements for aerosol, tube, and liquid products.
- Previous experience performing quality inspections in a regulated manufacturing environment preferred.
CRITICAL SKILLS AND ABILITIES:
- Proficient in the use of personal computers and quality measuring instruments.
- Strong attention to detail with excellent documentation accuracy.
- Ability to prioritize work, manage multiple responsibilities, and work independently with minimal supervision.
- Capable of performing effectively in a fast-paced manufacturing environment with changing priorities.
- Strong problem-solving and decision-making skills.
- Excellent verbal and written communication skills.
- Ability to maintain concentration while performing detailed quality inspections.
- Demonstrated initiative, technical aptitude, and commitment to achieving departmental and company objectives.
- Ability to work collaboratively with cross-functional teams while promoting a culture of quality and continuous improvement.
Title: IPQA II
Company: FORMULATED Solutions LLC
Location: Largo, FL
Category:
