QA Laboratory Technician II

The incumbent will perform laboratory sampling and testing, environmental monitoring, microbial identifications assuring compliance with regulatory agencies and procedures.  Responsibilities are to be performed in compliance with good laboratory practices (GLP), GMP, QSR, MDSAP, safety and environmental regulations.

1. Perform sampling and testing (i.e., purified water, environmental, bioburden, peel strength, dye immersion, saline solutions, etc).
2. Perform bioburden analysis (Dilution and Rapid method) 
3. Perform purified water analysis (Filtration method)
4. Perform environmental monitoring (Particle Count & Air Sampling).
5. Perform peel strength using INSTRON equipment.
6. Perform chemical analysis for saline solutions. 
7. Perform microbial identification using BIOLOG system or other applicable equipment. 
8. Perform temperature monitoring, following applicable procedures.
9. Sterilize materials using Steam Autoclave.
10. Clean laboratory Glassware and equipment use during analysis. 
11. Inventory control for laboratory reagents, standards solutions, and supplies. 
12. Verify periodically the expiration date of laboratory reagents and standards solutions.
13. Review documentation.
14. Perform saline solutions disposition.
15. Prepare laboratory solutions and standard as per procedure.
16. Perform analytical balance verification.
17. Notifies laboratory supplies and equipment inventory needs to perform analysis.
18. Perform troubleshooting and preventive maintenance to laboratory equipment.
19. Generate NCR in electronic system and participates in Laboratory Investigations.
20. Complies with good laboratory practices (GLP), GDP, GMP, MDSAP, QSR, safety and environmental regulations.
21. Complies with safety and environmental regulations.
22. Trains personnel when necessary.
23. Prepare pronto files.
24. Support the ROLESS program auditing the area and maintaining the area in compliance with the program.
25. Supports other areas and Coopervision sites as required (i.e., special tests, validations etc.).

Knowledge, Skills and Abilities

• Able to work overtime, different shifts, and weekend as per business needs. 
• Able to work under minimum supervision. 
• Good oral and written communication skills (English/Spanish).
• Ability to read, writes, and comprehends simple instructions in English and Spanish.
• Knowledge of Microbiological and chemical Laboratory methods and techniques.
• Basic computers skills (Excel, PowerPoint, Word).
• Knowledge of QSR (Quality System Regulations) and ISO 13485.
• Executes job responsibilities as established in the Standard Operating Procedures (SOP).
• Knowledge in Aseptic techniques
• Knowledge and compliance with Good Laboratory Practices (GLP) and Safety management as per SDS.
• Leadership skills.
• Teamwork oriented.
• Initiative and problem-solving skills.
• Good interpersonal skills at all levels.
• Highly motivated, self-starter, and responsible person.

Experience:

• At least one (1) year of experience in a Medical Device Industry and Quality Assurance Laboratory. 
• Knowledge in laboratory equipment’s (Analytical balance, Incubator, Autoclave, Air Sampler, Particle Counter, Colony Counter, Refrigerator, Rapid Detection System, pH meter, conductivity meter, Total Organic Carbon (TOC), INSTRON

Education:

• Bachelor’s degree in microbiology.

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CooperVision Manufacturing Puerto Rico LLC is  an Equal Employment Opportunity Employer and takes affirmative action to employ Women, Protected Veterans, People with Disabilities, and Minorities, regardless of Sexual Orientation and Gender.