PRIMARY PURPOSE:
The In-Process Quality Assurance II (IPQA II) supports product quality and compliance through production floor oversight, in-process and finished product inspections, and real-time review of manufacturing and cleaning records. This position verifies that manufacturing and packaging activities meet approved specifications, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Formulated Solutions’ data integrity requirements. The IPQA II serves as a liaison between Quality and Production to identify quality concerns, support timely resolution, and maintain accurate documentation. This role also provides personnel training, assists with quality investigations, and supports continuous improvement across manufacturing operations.
MAJOR DUTIES AND RESPONSIBILITIES:
Production Floor Quality Oversight
- Follow all applicable company policies, SOPs, quality standards, and safety requirements.
- Demonstrate, reinforce, and train personnel on GDP and cGMP requirements in controlled areas.
- Perform in-process and finished product inspections using appropriate measuring equipment, including calipers, crimp gauges, pressure gauges, and scales.
- Perform and document required Acceptance Quality Limit (AQL) visual inspections as specified in the master batch record.
- Verify pre-production and post-production line clearance activities to support proper material accountability and prevent mix-ups.
- Demonstrate proficiency in finished product inspections across all applicable production lines.
- Serve as a liaison between Quality and Production to help prevent, identify, escalate, and resolve quality events on the production floor.
Documentation Review and Data Integrity
- Perform real-time, in-process review of each batch record in its entirety, verifying completeness, accuracy, and compliance with approved requirements.
- Perform real-time review of cleaning records to confirm required activities are properly documented.
- Identify documentation discrepancies and coordinate timely correction in accordance with approved procedures.
- Accurately review and record data in accordance with Formulated Solutions’ current data integrity policies.
- Monitor, verify, and review monthly logbooks, as applicable, including temperature, pressure differential, and equipment logs.
Instrumentation, Samples, and Label Control
- Perform required daily instrumentation verification and confirm that calibration status is current before use.
- Accurately collect, label, and deliver retain samples, customer samples, analytical laboratory samples, microbiology laboratory samples, and stability samples as required.
- Perform label issuance and reconciliation activities in accordance with approved procedures.
- Perform annual retain sample inspections and destruction activities in accordance with established requirements.
Quality Support and Continuous Improvement
- Assist the IPQA Manager and IPQA Supervisors with quality investigations, including gathering relevant documentation and production floor observations.
- Provide quality support to Operations, Laboratory, Warehouse, and other departments as needed.
- Promote teamwork, continuous improvement, and customer satisfaction through consistent application of quality standards and effective communication.
- Perform other duties and participate in activities as assigned by Quality Management.
QUALIFICATIONS:
- High school diploma or equivalent.
- Working knowledge of FDA regulations applicable to drug products and/or medical devices.
- Knowledge of cGMP, GDP, and data integrity requirements in a regulated manufacturing environment.
- Knowledge of inspection methods and critical quality parameters for aerosol, tube, and liquid products.
CRITICAL SKILLS AND ABILITIES:
- Ability to use a personal computer, applicable software, and measuring devices accurately.
- Strong attention to detail, with a thorough and accurate approach to inspections, documentation, and data review.
- Ability to establish priorities, work independently, and complete assigned responsibilities with minimal supervision.
- Ability to manage fluctuating workloads and shifting priorities while maintaining focus and quality standards.
- Ability to identify, troubleshoot, and help resolve recurring quality and documentation issues.
- Clear and concise verbal and written communication skills.
- Ability to work collaboratively with Quality, Production, and other departments.
- Ability to maintain concentration and perform accurate work in a fast-paced manufacturing environment.
