Job Description

The incumbent will perform chemical analysis assuring compliance with regulatory agencies and procedures.



The incumbent will perform chemical analysis assuring compliance with regulatory agencies and procedures.

Qualifications

Knowledge, Skills and Abilities:

Knowledge in chemistry laboratory instruments and troubleshooting (GC, HPLC, FTIR, UV/VIS, pH, Karl Fischer, etc.) Good skills of sampling techniques, chemical laboratory methods and techniques Good skills in analytical chemistry concepts (i.e., concentration determinations, chemical formulations, etc.) Good technical writing skills Teamwork oriented Good communication skills Initiative and problem-solving skills Able to work overtime, if necessary, with minimum supervision Good oral and written communication skills in both English and Spanish Ability to read, writes, and comprehends instructions in both languages English/Spanish Knowledge of QSR (Quality System Regulations), ISO13485, Good Laboratory Practices, Good Manufacturing Practices, safety, and environmental regulations Computer skills (i.e., Excel, Word, PowerPoint, etc.) Good mathematics skills (i.e., average, rounding rules, multiply, divide, add, subtract, percentage, linear regression, standard deviation, relative standard deviation etc.). Good interpersonal skills at all levels. Highly motivated, self-starter, and responsible person. Demonstrates accuracy and thoroughness. Looks for ways to improve and promote quality. Applies feedback to improve and promote quality.
Unexpired Puerto Rico driver's license is required since the position requires to

operate pallet jack or finger

as usual and integral part of the job.

Experience:

At least four (4) years of experience in medical devices or pharmaceutical industry and chemical quality laboratory. Demonstrates Initiative and problem-solving skills. Good communication skills. Experience in equipment as HPLC, GC, FTIR, UV/VIS, titrations, pH, others.
Experience in HPLC and GC troubleshooting.

Education:

Bachelor's degree in science with major in Chemistry

Essential Functions & Accountabilities:

Trains personnel when necessary. Executes job responsibilities as established in the Standard Operating Procedures. Executes protocols and engineering studies related to laboratory processes. Performs sampling (materials, components, other as required). Performs chemical analysis of materials, components, manufacturing materials, monomers and other applicable test as required. Performs chemical analysis disposition. Assures materials are release on time. Reviews documentation. Challenges equipment performance verification. Execute validation protocols. Generates, evaluates, and investigates nonconformance (NCR's) and assure to close in a timely manner. Complies with good laboratory practices (GLP), QSR, ISO 13485, safety, and environmental regulations. Generates laboratory investigation and assures to close in a timely manner. Performs temperature monitoring, as applicable. Cleans laboratory glassware and equipment used during analysis. Keeps laboratory areas clean and organized. Performs troubleshooting and maintenance to laboratory equipment. Notifies laboratory supplies and equipment inventory needs to perform analysis. Supports other areas as required (e.g., special tests for validations) Verifies periodically the expiration date of materials, components, manufacturing materials, reagents, standards solutions. Coordinates and/or execute laboratory's equipment preventive maintenance. Generates DCO's, ECO's, and Engineer study. Create and revise procedures. Complies and Maintain 6S (ROLESS) in the Laboratory. Non-Essential Functions: Coordinates Lab. daily activities to assure process flow including PM, Cal, and repair. Prepares pronto files. Assists to Lab. Team Leader duties.

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.

Safety & Occupational Health Responsibilities

Complies with Safety and Occupational Health Policy and procedures. Complies with Hazardous Communication program. Notifies immediately all accidents or incidents occurred in work area.
Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable.


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