Quality Technician

Position Summary

A Quality Technician is responsible for maintaining a high level of quality and customer satisfaction while meeting production schedules in a fast-paced, high-throughput industrial setting. The Technician will be responsible for the Quality Control of many product types including chemical buffers, biological diluents/reagents, coated plates, and/or assembled kits for customer order fulfillment. The associate will be responsible, under minimal supervision, to follow established SOPs to support the goals of the department. They will be expected to assist in troubleshooting problems and keeping SOPs up to date. This position will also assist the Quality team in performing internal audits, authoring SOPs, and driving the completion of CAPAs and other continuous improvement processes. Some degree of professional latitude, creativity and self-management is expected. 

Duties and Responsibilities:

• Responsible for ensuring compliance in accordance with documented procedures for all aspects of operations as well as functional responsibility.
• Assit with ISO and GMP internal audits and follow-up as needed. See that discovered deficiencies are addressed and corrected as needed.
• Review Production and Quality documentation for adherence to Good Documentation Practice requirements and perform final batch release of intermediate and finished product in a timely, compliant manner.
• Verify equipment or equipment records on a weekly or monthly basis.
• Review Quality documents and operational processes for conformity to the Quality Management System.
• Provide support for generating, reviewing, and reporting Certificates of Analysis per customer and company standards.
• With minimal supervision, be able to perform quality control functional testing and data evaluation to determine disposition of all product components, including doing kit retesting for expiration date extensions and stability testing functions. 
• Be able to make basic laboratory calculations to determine pass/fail criteria of quality testing. 
• Perform daily record-keeping and/or scheduling and disposition, including daily updating of quality control summary databases.
• Specific duties may vary depending upon departmental and company requirements

Experience and Qualifications:

• High school diploma with a strong understanding of the scientific process
• 0-1 years of experience in a research or clinical laboratory setting.
• Continued education in science, biology, chemistry or equivalent

Knowledge, Skills and Abilities:

• Demonstrate ability to process and characterize incoming biological reagents such as proteins and antibodies according to company procedures, and effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
• Familiarity with MS Office suite
• Excellent interpersonal skills and ability to work well with personnel at all levels
• Strong oral and written communication skills
• Attention to detail
• Demonstrate an aptitude for learning and adhering to standard laboratory techniques and safety precautions as presented
• Complete appropriate documentation to support testing procedures including data capture, forms, logbooks, and inventory batch records