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