CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the worlds leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; 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/
JOB TITLE: Manufacturing Laboratory Operator- Solution Preparation Laboratory
DEPARTMENT: Quality
JOB SUMMARY
The incumbent will be in charge for the preparation and transportation of the saline solutions used for the manufacture of contact lenses.
Responsibilities are to be performed in compliance with good laboratory practices, GMP, QSR, MDSAP, safety and environmental regulations.
ESSENTIAL FUNCTION
Prepares the saline solutions as per applicable procedures.
Transport saline solution using electric car from Solution Preparation Lab to Manufacture room (e.g. Phase G, etc.).
Supports all manufacturing lines providing the saline solutions as required.
Performs equipment verification (e.g. analytical balance, top loading, etc...)
Performs temperature monitoring.
Complies with good laboratory practices, GMP, MDSAP, QSR, safety and environmental regulations.
Complies with safety and environmental regulations.
Cleans laboratory containers and equipment used.
Organize and segregate saline solutions in the refrigerator accordingly.
Reports raw materials usage in BPCS.
Performs inventory of saline solutions in refrigerator area.
Performs periodically inventory of materials.
Reviews of documentation.
Perform laboratory supplies and equipment inventory needs to manufacture saline solutions.
Trains personnel when necessary.
Performs and reports work in a safe and organized manner
Stay current on all job related or function related information and/or training.
Complies and Maintain 6S (ROLESS) in the Solution Preparation Laboratory Area.
Supports validation activities
Prepares pronto files.
POSITION QUALIFICATION
KNOWLEDGE, SKILLS AND ABILITIES
Able to work with minimum supervision.
Able to read and understand simple instruction in languages, English and Spanish.
Applies communication skills to work as a team group
Complies with the Quality System Regulation (QSR) and ISO 13485.
Executes job responsibilities as established in the Standard Operating Procedures (SOP).
Knowledge and compliance with Good Laboratory Practices (GLP) and safety knowledge and reagents management as per SDS.
Leadership skills
Teamwork oriented
Initiative and problem-solving skills
Able to work overtime if necessary, with minimum supervision
Computer skills (i.e. Excel, Word, PowerPoint, etc.)
Good interpersonal skills at all levels
Highly motivated, self-starter, and responsible person
Operate material handling equipment to support saline solution dispatch to manufacturing refrigerators
WORK ENVIRONMENT
The noise level in the work environment is usually moderate
Needs to walk, stand, use hands to finger, handle, or feel; sit and reach with arms; lift and/or move up to 50 pounds; requires close vision
Utilizes reading, writing, speaking skills, analytical capacity and judgment to solve problems
Applies communication skills to perform work and speaks clearly and persuasively in positive or negative situations
Incumbent could be exposed to fumes of chemicals.
EXPERIENCE
At least six months of experience in Medical Device or Pharmaceutical
EDUCATION
Associate Degree in Science
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