Summary

Perform daily in-process control support functions including but not limited to sampling and analysis of incoming components and labels, production inspection audit control, establishment of standards, resolution of production component issues, and special projects as assigned by supervisor or manager. Contributes to improvements in the operation of production by reporting to management issues of non-conformance and making suggestions to improve departmental objectives and compliance.

Essential Duties and Responsibilities

• Perform and maintain incoming component and label inspection program per standard operating procedures.

• Perform review, per standard operating procedure, to include collection/maintenance of samples.

• Performs and directs in-process inspection audit control where required for filled and assembled goods as needed.

• Maintains an effective system of handling physical standards, artwork, and specifications for components and labels.

• Perform and maintain calibration of plant scales per standard operation procedure and schedule. Liaise with outside scale vendor for OOS, replacement, and annual calibration.

• Control and maintain retain room in organized manner including retention control per standard operation procedure.

• Assists departmental and organizational management in preparing, maintaining, and monitoring compliance to internal operating procedures. Participates in the establishment of organizational quality control goals and objectives for quality control audit inspection.

• Implement audit inspection programs in accordance with organizational quality control requirements.

• Participates in cGMP and/or regulatory quality audits where necessary.

• Participates in intra-departmental meetings designed to improve product quality efficiency and promote a continuous improvement environment.

• Participates in validation programs as necessary.

• Assures compliance to GMP’s (calibrations, proper documentation practices, etc.) and directs internal housekeeping program where necessary.

• Reviews all inspection and certification documentation of non-conformances and inconsistencies. Performs further evaluation of goods when determined necessary.

• Follows and enforces company safety programs to ensure a safe working environment.

• Exercises and monitors GMP and safety compliance requirements in the work environment.

• Ensures compliant conditions for line start-up to include proper components, approved product, documentation, standards, clean and sanitized equipment, etc.
• Performs batch reconciliations in a timely manner.

• Releases bulk and finished goods batches for filling and shipment.

Qualifications

• High school diploma or general education degree (GED) and one to three years related experience and/or training.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Qualified candidate must be proficient in the use of Microsoft Excel.
• Ability to compute rate, ratio, percent, convert English/Metric units and apply concepts to practical situations.
• Ability to speak, read, and write in English. Bilingual in Spanish is a plus.