QC-IPC - 3rd Shift

QC IPC

Positional Responsibilities & Duties

The In-Process Quality Control (QC IPC) is responsible for evaluating product quality through the evaluation of various product tests related to product ingredients and packaging based on department specifications. This position will resolve product discrepancies in production as needed

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Perform real-time quality checks and testing during the manufacturing process, including sampling of in-process materials and finished goods to ensure adherence to established quality specifications.

· Inspect routine tests such as pH, weight, particle size, moisture content and ensure that product specifications are consistently met during production.

· Monitor in-process parameters to ensure they are within established limits, ensuring the quality and consistency of the production process.

· Record and report testing results, flagging deviations and recommending corrective actions when necessary.

· Work closely with the production team to identify potential quality issues during the manufacturing process and address them promptly.

· Provide support and guidance on quality control standards and testing procedures to ensure alignment between production and quality control.

· Communicate with the production department regarding in-process control results and assist in implementing corrective actions for any out-of-spec results.

· Ensure that all in-process control activities and test results are properly documented and compliant with GMP, FDA, and other regulatory guidelines.

· Maintain accurate and up-to-date records of all quality checks, tests, and corrective actions.

· Review and verify batch production records (BMR) and in-process documentation for completeness and accuracy.

· Participate in the preparation of reports related to in-process quality metrics, providing insights to management on trends, issues, and areas for improvement.

· Identify, investigate, and document any deviations from established quality standards during the production process.

· Support the resolution of quality issues and assist in conducting root cause analysis to prevent future occurrences.

· Ensure that testing equipment used for in-process control is calibrated and maintained according to standard operating procedures (SOPs) and regulatory requirements.

· Notify management of any equipment malfunctions and assist in troubleshooting and repair processes.

· Keep a record of calibration and maintenance schedules to ensure compliance and optimal performance of lab instruments.

· Contribute to continuous improvement initiatives to enhance product quality, reduce waste, and streamline manufacturing processes.

· Recommend improvements to in-process control procedures to improve product consistency and efficiency.

· Participate in training and process optimization projects to help maintain a high level of quality assurance across all production processes.

· Assist in preparing for and participating in internal and external audits, ensuring that all in-process control documentation is organized and ready for inspection.

· Ensure that any audit findings related to in-process control are addressed in a timely manner and that corrective actions are implemented.’

· Conduct cleaning verifications by performing visual inspections and swap tests.

· Responsible for the approval of the production and packaging lines after cleaning activities