Under the supervision of the Quality Systems Manager, responsible for support with the following Quality Systems: CAPA, Customer Complaint, MRB, QC Inspection and QA Release. The QA Specialist I will assist in maintaining the Quality Systems program. In addition, this position may also conduct inspections of components for diagnostic test kits during the various stages of processing according to approved standards. Such activities ensure compliance with GMP/QSR requirements, ISO standards, customer approved procedures and finished product specifications.
1. Assists in maintaining the Quality Systems programs by being a designated back-up person and perform those duties, as needed.
2. Develops systems for the logging and tracking of Quality Systems data using information technology systems such as computerized databases.
3. Performs quality investigations for CAPAs and/or Customer Complaints to determine root cause(s) and provide/implement corrective actions.
4. Perform timely reviews and sign off of final product release for manufacturing departments. Must confirm that all necessary information is present, accurate, within Customer and in-house specifications, and conform to cGMP. This requires adherence to cGMP and Quality Standards for the building, assembly, packaging, labeling, sample shipping, and ultimately shipment of the final lot.
5. Reports on the trends to management so that quality improvements activities are undertaken on the items which represent the most opportunity for savings to SLI. Uses quality tools such as pareto charts to distinguish between the vital few items and the trivial many.
6. Read, interpret and follow RMSs, SOPs and other procedures.
7. Prepare and file necessary Quality Systems paperwork.
8. Maintain and update related Quality Systems databases using Microsoft Word, Excel, SmartSolve, etc.
9. Generate weekly and monthly Quality Systems reports, as necessary.
10. Lead, participate, and/or take meeting minutes for Quality Systems meetings.
11. Perform QC inspections and sampling.
12. Ensure proper documentation of inspection activities.
13. Recognize and segregate non-conforming product and material defects.
14. Communicate with and provide essential quality information to department management.
15. Maintain a safe, organized, and clean working environment for employees.
16. Provide training to staff, as required.
18. Other related duties as requested.
Requires an Associates degree or higher educational level or equivalent
Requires 3 years quality experience in an ISO 9001/13485 and QSR or other regulated quality system environment
Ability to write legibly and record results accurately in appropriate documentation
Vision must be correctable to normal
Must be able to read and write English fluently
Must be proficient in Microsoft Word, Excel, Outlook, and PowerPoint
Working Conditions/Physical & Mental Demands:
Essential duties are performed in a temperature controlled environment setting. Requires ability to stand and sit for extended periods of time. It is necessary to climb stairs and perform moderate lifting (10-25 lbs.). Testing requires the use of both hands with some repetitive motion. Busy, fast pace work environment.
Benefits Include: Medical, Dental, 401K with company match, tuition reimbursement and incentive compensation.