Quality Technician 2

Although Corporate Quality Assurance is responsible for overseeing the Quality Assurance program, all personnel have defined roles and responsibilities and should be familiar with this SOP. Note that roles at some facilities may overlap. The roles and responsibilities should be used as a guide to ensure that personnel are qualified by education and training to accomplish their respective jobs.   

Description

(Include responsibilities, decisions, and/or recommendations for each task)

Frequency

(Daily, weekly, monthly, quarterly, annual)

Maintain the Laboratory Quality Management System.

Daily  

Maintain Safety Data Sheets (SDS) program: hard and e-copy files routine updates.

Daily  

Perform and document analytical testing of raw ingredients, in-process goods, packaging materials, customer complaint and returned goods samples.

Daily

Assist in maintaining QC Laboratory in audit-ready state and cGMP compliant. Maintain smooth laboratory functionality.

Daily  

Generates Standard Operation Procedures (SOPs) for new test methods, quality, and operational requirements.

Daily  

Trains and document training on new methods and requirements.

Daily

Conducts environmental monitoring of water, air quality, production area temperature.

Monthly

Document/report results as required. Report any non-conforming results to QA Manager and Production Supervisor.

As Needed

Routine inspections of Finished Goods (FGs) and components to ensure product conformance to standards: Appearance, Color, Lot Codes, Defect Levels, Incoming/New Label Approvals etc.

Daily

Member of Corrective Action and Preventative Action (CAPA) Team: A. Perform non-conformance investigations. B. Re-inspections, retesting, identifying FG warehouse locations and quantities (Internal and External). C. Perform lot code searches and product recovery. D. Report all findings to Quality and Operations Management. E. Document corrective and preventative actions. Follow-up monitoring to gauge the effectiveness of the corrective action.

As Needed

Member of the Change Control Board: A. Assist CCB Moderator (QC Manager) in documenting and communicating follow-ups to change control requests. B. Assist in Change Control Coordinator and properly document any new change request using the appropriate form and prepare meeting notes for publication.

As Needed

Promote good customer relations: A. Takes the lead in New Product Trials and Start-up (ensuring all required documentation is received and communicated as necessary). B. Validate new customer test methods and instrument techniques as required. C. Train QC personnel o methods and instrument techniques as required.

As Needed

Assist in maintaining the Quality Hold Program.

Daily

Assist in conducting Quality System Audits (Internal/External) and reports results to QA Manager.

As Needed

Communicates quality concerns to Operations Team and assists in determining root cause analysis.

As Needed

Complies, interprets data, and reports results to QC Manager.

Daily

Assist in regulatory activities (domestic and international) as needed.

As Needed

Quality Assurance recommends a minimum of a 2-year degree in chemistry or chemical engineering, with excellent mathematics and problem-solving skills. Technical background and/or experience in Quality Assurance a plus. 2. Bachelor of Science Degree in Chemistry or Biology. 3. Good Documentation Practices (GLP). 4. Good Laboratory Practices (GLPs). 5. Effective Communication Skills: written, verbal and behavioral. 6. Current Good Manufacturing Practices (cGMP). 7. Good decision making and good troubleshooting skills. 8. Bilingual English/Spani