QA Formulation Lab 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.

Essential Functions & Accountabilities:

• 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.

Quality System Responsibilities

• Complies with the Quality System Regulation (QSR).
• Executes job responsibilities as established in the Standard Operating Procedures (SOP).
• Follows the documentation procedures.
• Completes training for the qualification and certification, as required, to execute the job.

Environmental, Occupational Health and Safety Responsibilities

• Embraces, supports and aligns with corporate social responsibility policies while complying with applicable environmental, health and safety laws, regulations, procedures and corporate standards.
• Notifies conditions, near misses, accidents and incidents including environmental, that occurred in site’s premises to prevent or eliminate any risk or exposure.
• Communicates any process changes that may impact Environmental, Health, Safety and Sustainability aspects to ensure compliance with regulatory obligations including protection of people and the environment.
• Promotes a safe and environmentally friendly workplace.

Travel: 

N/A

Qualifications

Knowledge, Skills, and Abilities:

• 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

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.

  “Estamos comprometidos con la igualdad de oportunidades laborales independientemente de la raza, el color, la ascendencia, la religión, el sexo, el origen de nacionalidad, la orientación sexual, la edad, la ciudadanía, el estado civil, la discapacidad, el género, la identidad o expresión de género o la condición de veterano. Estamos orgullosos de ser un lugar de trabajo con igualdad de oportunidades”.

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