Qa Lab Technician Ii

QA Lab Technician II - JUA2028

Description

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

Postion: QA Laboratory Technician II-Microbiology

Job Summary

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.

Essential Functions & Accountabilities

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

Knowledge, Skills and Abilities:

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

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.

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

Job: QA Operations

Primary Location: Puerto Rico-Juana Diaz

Organization: CVI Americas Manufacturing Operations (AMO)

Schedule: Full-time

Unposting Date: Ongoing