MEC Laboratory Tech I - Tellus Solutions
Barceloneta, PR 00617
About the Job
Tellus Solutions is in partnership with a committed biopharmaceutical company in Barceloneta focused on providing innovative therapies. Your technical expertise as a MEC Laboratory Tech I in the area of laboratory test (Raw materials, in process sample and finished product) will contribute to our client's innovative therapies which will impact the quality and duration of life.
Job Description:
Purpose:
Job Description:
Purpose:
- Perform microbiological testing required for water used in the manufacturing process, raw materials, in process samples and final product following specifications.
- Perform microbiological testing such as bioburden and endotoxin to water samples used in the product manufacturing process and to the final product. Perform in process product testing such as bioburden, contamination check and endotoxin.
- Perform all the facilities and utilities environmental monitoring using Climet, RCS, and surface sampling. Perform gowning sampling as part of routine program and for qualification/routine requirements.
- Follow Good Manufacturing Practices (cGMP), safety rules and Good Laboratory Practices (GLP). Provide support to the manufacturing area during filling process.
Responsibilities:
- Responsible for performing the environmental monitoring to the manufacturing area and laboratory test (Raw materials, in process sample and finished product) following the established parameters ( policies, FDA, cGMP) and applicable regulations without impact to the manufacturing cycle or laboratory workflow.
- Document The results of the test and analysis performed accurately.
- Perform maintenance to laboratory equipment.
- Identify, collect, and submit samples to the MEC laboratory.
- Assure that all samples are collected, tested, and authorized as per schedule and following applicable procedure.
- Assist the MEC Laboratory Service, to maintain adequate inventory of materials, reagents, culture media, reference material, and general-purpose material for the operation of the Environmental Control Laboratory.
- Complete training and certifications on time as established in the training curriculums.
- Control and management for the disposal of domestic, biomedical, and hazardous wastes of the MEC area as applicable, ensuring compliance with Local and Federal regulations following the procedures and policies of the plant, division, and the corporation.
- Participate and promote continuous improvement to the Environmental health and safety (EH&S).
Qualifications:
- Associate degree in Natural science with major in Biology, Chemistry, Microbiology and or Minimum of One year of experience in the Pharmaceutical industry or equivalent in a microbiology laboratory.
Source : Tellus Solutions
