Responsibilities:

·      Continuously fully comply with all quality and regulatory standard requirements.

• Conduct microbiological testing such as: Bioburden, Microorganism Identification, Media Preparation, Growth Promotion, Endotoxin, and Sterility Testing using qualified laboratory equipment and following the applicable written procedures.
• Conduct environmental sampling to the manufacturing controlled areas supporting the ECA (Environmental Controlled Area) Monitoring Program.
• Prepare reports related to microbiological analysis, ECA Monitoring Program, and monthly metrics.
• Review and approve data related to the microbiological testing ensuring compliance to requirements set forth in applicable standards and test methods. 
• Train new personnel and existing on ECA controls and ensure that the applicable requirements are.
• Train new personnel and existing on microbiology testing and proper testing techniques.

·      Assure the laboratory equipment is qualified, calibrated and within PM (Preventive Maintenance) program.

·      Conduct analytical method qualification and laboratory equipment validations.

·      Provide support during audits (FDA, TUV or other related).

• Review and approve reports of Biological Indicators or sterility analysis (EtO).
• Provide support to the sterilization processes validation.
• Review of Biocompatibility documents.
• Coordinate and manage the testing conducted by external laboratories according to procedures.
• May be required to perform other duties as required to the operations and according to his/her abilities and skills.
• Comply with Health and Occupational Safety politics (EHS).

Supervisory Responsibilities:

• May coordinate the work of other associates to ensure timely attainment of results.

Physical Requirements:

·      Sedentary Work: Exerting up to 50 lbs. of force occasionally. Generally involves sitting most of the time.

·      Very good visual acuity.

Mental Requirements:

• Complete detail and accurately all documents generated in their work.
• Solve complex problems using their knowledge in procedures. Must be able to observe and note minute inconsistencies.
• Must be able to generate, follow, and explain detailed instructions and inspection procedures.
• Must be able to complete detailed documentation accurately.

Required Skills:

·      Strong analytical skills

·      Strong laboratory aseptic techniques

·      Effective interpersonal skills

·      Basic PC skills

·      Math skills

• Microbiology and sterility testing execution skills

·      Communicate (read, write, and understand) In English and Spanish.

Required Experience:

·      At least 3 years of experience as an exempt microbiology analyst with at least endotoxin and bioburden method validation experience preferable in medical devices.

·      Experience in mold identification is a plus along with biocompatibility data knowledge.

·      Knowledge in identification of microorganisms.

·      Knowledge in microbiology lab equipment installation and operational qualification validations.

Required Education and Training:

·      B.S. in Microbiology or Biology, or related discipline from accredited university