Job Description

Essential Functions & Accountabilities:

• Executes analysis on raw materials for Incoming Quality, intermediate and finished goods for Final Release.

• Executes laboratory internal controls.

• Collaborates with the test required as part of equipment qualification and method validations.

• Tests to be performed may include bioburden and sterility testing, filter integrity test, pH, osmolality, viscosity, endotoxin test, microbiological control as environmental monitoring, plate reading and general assays for microorganisms’ identification.

• Records results on inspection forms and reports. Maintains department files for readily retrievable access of records.

• Notifies designated supervisor or engineer when result exceeds acceptable limits or when major incidents are noted.

• Coordinates external testing, samples shipment, tracking and test results report, review.

• Performs tasks under Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLP), Good documentation Practices (GDP), safety techniques and aligned with the regulatory standards such as USP, ACS, Ph. Eur, ASTM for laboratory testing and improvements.

• Performs environmental monitoring sampling and testing or coordinates with contractors when required.

• Collaborates with Lean initiatives such as 5S and Gemba walks.

• Collaborates with inventory tracking and notifies the supervisor to maintain the stock of materials.

• Collaborates in training of new personnel in specific testing when required.

• Executes cleaning activities to maintain order and disinfection of specific areas.

• Performs equipment user´s preventive maintenance and documents appropriately.

• Collaborates in documentation improvement, such as SOPs, forms, or logbooks.

• Collaborates in continuous improvement of laboratory operations.

• Supports NCMR and CAPA investigation when needed, supports audits when required.

• Performs laboratory coordination functions when required.

Knowledge, Skills and Abilities:

• Comprehend and apply written instructions, specifications, and methods in both English and Spanish.

• English advanced level, read and write technical documents.

• Dominates GMP’s and GLP’s, GDP´s. Knowledge in ISO 17025 is a plus.

• Dominates aseptic technique, manual, semi-automated, automated testing, and equipment.

• Detail oriented, effective time management, adaptability to change, team working, proactive, collaborative, continuous improvement thinking and acting, and open to escalate concerns on time. Solves laboratory and testing issues, performs troubleshooting, interacts with vendor. Exercise leadership, able to manage people.

Work Environment:

• Sitting for extended periods of time.

• Get into laboratory rooms.

Experience:

• A minimum of 4 years of previous work in highly regulated industries such as medical device or pharmaceutical manufacturing in similar positions is required.

• Experience with aseptic technique, manual, semi-automated, automated testing, and equipment is desirable.

• Experienced with GMP’s and GLP’s, GDP´s. Knowledge in ISO 17025 is a plus.

Education:

• Technical Degree in Microbiology laboratory or Chemical laboratory is required.

• Current membership in the College of Microbiologists, if applicable