Lead Quality Control Inspector

Position Summary: The Quality Control lead position supports the Quality Control Supervisor in the requirements for inspecting incoming materials, in-process inspections, and finished goods (fabricated and assembled) to ensure adherence to company quality standards and customer specifications for the following inspection functions:

• Received Raw Materials
• First Article review and acceptance
• In-Process Inspection
• Final Inspection Release of Finished Goods
• Non-Conformance Reporting

Shift: 5:30 am to 2:00 pm

Responsibilities:

• Train employees as assigned by QC Supervisor ensuring documented training records are completed.
• Approve or reject raw materials with respect to quality standards and communicate results to all pertinent parties.
• Support QC Supervisor in the maintenance and accuracy of inspection procedures and QMS documentation.

• Oversee and support inspectors during the inspection of product during various phases of production and throughout the manufacturing process, ensuring all inspections are properly completed and documented.

• Take active role in investigating and resolving problems related to quality and product.
• Effectively communicate, lead and support inspectors and production personnel as initial technical support contact.

• Initiate nonconformance reports (NCR) for all non conforming material identified throughout operations.
• Assists in monitoring the disposition close out of all non conformance reporting

• Participate in meetings as required (safety, problem solving, etc.)
• Participate in process improvement teams and/or completes relative documentation when required.
• Support QC Supervisor in suggesting or communicating ideas for continuous improvement to maximize product quality and minimize costs.
• Prepare and submit reports to the quality manager or supervisor.
• Support compliance with established practices, polices, to meet customer/contractual obligations and in compliance with regulatory codes and standards.
• Comply with all safety requirements ensuring work areas meet standards.
• May be required to report to multiple facilities within a 2-mile radius.

Additional responsibilities can include the following:

• Support effective management of Quarantine areas.
• Responsible for facilitation of document control and training programs
• Participate in the management of equipment, process risk assessment.
• Supports environmental monitoring of cleanrooms and bioburden results. Assists in solutions for microbial and particulate failures as needed

• Assist in the continuous growth of the Quality Department.
• Job Order document review and release.

Preferred Skills:

• Education/Training: Associate degree in a technical or scientific skill desired, or High School Diploma or equivalent with 4-6 years of experience in quality control inspections.

• General understanding of global pharmaceutical product regulations with experience with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
• Minimum of 4-6 years’ experience with technical documentation for quality activities, such as corrective actions, quality audits, and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.
• Solid organizational and planning skills.
• Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
• Must be able to work effectively and lead others efficiently in a team environment.
• Good general mathematical skills.
• General computer skills.
• Must be able to use discretion and independent judgement
• Must be able to pay close attention to detail

• Ability to work flexible schedule based on operational needs
• Knowledge in using measuring tools such as calipers, gauges, measuring tape

• Knowledge with Syteline ERP is a plus