Quality Control Technician - 1St And 2Nd Shift

The Quality Technician is responsible for assisting with quality control functions that ensure products and processes conform to specification, regulatory requirements and customer expectations.

• Perform documentation review of production batch records with direction from the Quality Specialist and Quality Management
• Provide administrative assistance for the Quality Management System.
• Perform documentation review of production batch records. This includes identifying all non-conformances within the data and performing deviations, investigations, discrepancies, quality notes and root cause analysis in order to amend/document the issues.
• Perform room and equipment cleaning inspection and release for processing.
• Perform and document the inspection, sampling, preparing retains, testing, and release of raw materials.
• Perform QC lab testing, including Aw and LOD.
• Perform periodic checks on quality control equipment, measuring and test equipment according to standard operating procedures.
• Perform inspection of in-process and finished goods (FG-0398).
• Count and issue labeling materials as part of batch issue when requested.
• Set up and print labels.
• Process, review, close, and scan QMS records (e.g. CAPA, Complaints, documents…).
• Perform regularly scheduled QC tasks such as environmental monitoring testing, particle count and water testing.
• Performs other duties as assigned by management.

Qualifications and Skills:

• AS degree and 2 years of related experience and/or training or equivalent combination of education and experience.
• Prior experience in a medical device, pharmaceutical or FDA regulated facility. Demonstrated knowledge and mastery of job responsibilities/duties and understanding of the company standards.