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.