Quality Control Analyst

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDAregulated 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 inprocess 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 nonviable 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 Requalification 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:

• Bachelors degree of Science in Biology Microbiology Chemistry or similar field of study.

Required Experience and Skills:

• At least 1 year of relevant postdegree 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

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica origen nacional estado de veterano protegido estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by law.