Quality Control Analyst

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. 
Responsibilities:

• Performs laboratory solution preparation to be used for testing of raw materials, materials in-process and finished products.
• Performs physical testing of finished products, raw materials and stability samples, in accordance with company test methods. Responsible for reading EM Sampling (Microbial Air, Surface, Particulates), EM Plates Processing, TOC analysis, Conductivity, Nitrates, Compressed Gas Testing.
• Performs standardization of solutions and instruments as required and records results in official logs.
• Records all results of testing in logbooks, directly on report forms or into the laboratory computer system using proper documentation.
• Specific to Environmental and Utility Monitoring, the analyst will be responsible for maintaining the EM program to include the following:
• Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases.
• Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling.
• Provide data entry, review and approval as required.
• Provide summaries of test results to appropriate personnel as needed.
• Compile and evaluate environmental data for adverse trends.
• Directly support Performance Qualification activities.
• Perform routine monitoring of Personnel. - Compile and author Annual Reviews as required.
• Author and summarize Re-qualification, Performance Qualification, and Special Study protocols as required.
• Perform monthly and weekly sample accountability.
• Submit LIMS sample rejections. - Equipment Calibration and Management
• Filing data sheets and document control of logbooks - Other duties requested by Management.

Education Minimum Requirement:

• Bachelor’s degree of Science in Biology, Microbiology, Chemistry, or similar field of study.

Required Experience and Skills:

• At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.
• Evidence of good oral and written communication skills (i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills)
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Strong understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.
• Ability to sit, stand and move within workspace for extended periods,
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.
• Ability to lift up to 50 pounds.

Preferred Experience and Skills:

• Quality Control, Quality Assurance and/or cGMP experience