Qa Laboratory Formulation Tech Ii

The incumbent will be in charge for the preparation of the formulation used for the manufacture of contact lenses.

Also is accountable for the use of Laboratory Instruments operative systems and equipment. Responsibilities are to be performed in compliance with good laboratory practices, QSR, PAL, ISO 13485 regulations and; safety and environmental regulations.

The incumbent will be in charge for the preparation of the formulation used for the manufacture of contact lenses. Also is accountable for the use of Laboratory Instruments operative systems and equipment. Responsibilities are to be performed in compliance with good laboratory practices, QSR, PAL, ISO 13485 regulations and; safety and environmental regulations.
Experience:

At least three years of experience in Medical Device, Quality Laboratory and laboratory equipment (Viscometer, Karl Fisher, colorimeter, etc.)

Education:

Bachelor's degree in a chemistry or science
Prepares the monomer formulation as per applicable procedures.
Supports all manufacturing lines providing the monomer formulation as required.
Prepares pronto files.
Performs equipment verification.
Performs temperature monitoring.
Complies with good laboratory practices, QSR and ISO 13485.
Complies with safety and environmental regulations.
Participates in laboratory investigations.
Cleans laboratory glassware and equipment use during the mixing process.
Responsible to organize raw materials and segregate products in the freezer accordingly.
Reports usage of raw materials in BPCS.
Performs inventory of the monomer formulation in production area.
Performs periodically inventory of components.
Reviews of documentation.
Notifies laboratory supplies and equipment inventory needs to perform analysis.
Performs chemical analysis of monomer mixture (i.e. water content, absorbance, color, viscosity).
Trains personnel when necessary.
Coordinate the disposal of any unused materials, contaminated materials, or out of specification product.
Performs and reports work in a safe and organized manner
Stay current on all job related or function related information and/or training.
Challenges equipment performance verification.
Generates NCRs.
Notifies laboratories supplies and equipment inventory needs to perform analysis.
Complies and Maintain 6S (ROLESS) in the Formulation Laboratories Area.

Skills

Able to work with minimum supervision.
Dynamic and self-starter.
Able to work overtime if necessary.
Able to read and understand simple instruction in languages, English and Spanish.
Applies communication skills to work as a team group
Needs to apply analytical skills.
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.
knowledge and skills in analytical equipment
knowledge in chemistry instruments and troubleshooting (Viscometer, Karl Fischer, Colorimeter, etc.)
Good technical writing skills
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

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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.