PQ Inspector

Pharmaceutical Associates - Greenville, SC

Greenville, SC

Chemical Manufacturing

About the position

To provide customers a Quality product on a consistent basis. This is done by monitoring product quality routinely with various and physical inspections to assure it meets Quality Standards. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

Responsibilities

• Promote cGMP compliance in FDA/DEA regulated pharmaceutical manufacturing environment.
• Perform inspections throughout the packaging process on in-process samples as well as finished products ready for release.
• Perform inspections of the packaging rooms and packaging lines for clearance purposes.
• Record data and review documentation for cGMP compliance and accuracy.
• Develop a working knowledge of statistical based sampling plans.
• Continuously develop a working knowledge of cGMPs, SOPs, WIs, and FDA requirements.
• Segregate, quarantine, document, and investigate non-conforming material incidents.
• Initiate, document, and oversee Process Issues.
• Help to identify and present on-going initiative for continuous improvement to PAI's quality process.
• Perform in-line inspection equipment challenges.
• Calibrate and program in-line scales and document calibration.
• Help train new QA inspectors if needed.
• Coordinate the inspection of the labeling components with other departments in order to support packaging operations.
• Manage the labeling inventory and label storage area.
• Stage labeling items per the packaging schedule.
• Daily warehouse management transactions for amount verifications, bin transfers, approvals, spot counters, and amendments.
• Return packaging components to inventory from reconciliation in Ross/Red Prairie.
• Maintain inventory using WMS and inventory cards.
• Sample and inspect packaging components.
• Perform measurements with calipers and scales.
• Perform other related duties as required or assigned.

Requirements

• High school diploma, or GED equivalent and/or on the job education in a specific skill area.
• 12-18 months related experience and/or training, or equivalent combination of education and experience.
• Microsoft Software proficiency.
• Good math skills.