DUTIES AND RESPONSIBILITIES:

• Administrative assistance with SOP development and implementation, cGMP training, training record maintenance, and other duties related to supporting compliance with cGMP regulations and company SOPs.
• Perform mathematical and statistical calculations to verify or convert test result information.
• Perform testing in all departments in order to gain experience to assist in troubleshooting quality and safety issues.
• Maintain fully approved, scientifically sound protocols and written standard methodologies to be used in all analytical sections.
• Review and evaluate test data generated within technical areas and discuss any areas of doubt with analysts.
• Independently identify, investigate, and resolve or suggest solutions to analytical and administrative problems.
• Design and implement appropriate quality measures that meet or exceed the standards set by the Supervisor.
• Perform and provide basic evaluation of statistical tests (e.g. linear regression) to determine the quality and accuracy of data and report values.
• Communicate clearly and concisely to management and staff both orally and in writing.
• Administer and direct the training of all technical staff.
• Critically evaluate services offered by laboratory.  Recommend, develop, and implement new services; more accurate, efficient and appropriate test procedures; more accurate, efficient or cost effective equipment; and more efficient layout of facilities.
• Establish and implement procedures to ensure that assigned equipment is properly cleaned, calibrated/standardized, adequate for the testing performed and is maintained in good working order.  This includes maintaining equipment operating instructions, manuals, and required logbooks.
• Responsible for correct, ongoing implementation of all SOPs that apply to each area of the laboratory.
• Work closely with local management to ensure that clients receive good service, accurate results, and fast turnaround time consistent with superior analytical testing.
• Follow all guidelines and procedures of Eurofins Scientific.
• Work closely with operations to determine the best balance of quality and operational effectiveness while meeting corporate quality standards.
• Work closely with local management to ensure that laboratory facilities and equipment are well maintained and safe to use.
• Ensure that proprietary methodologies are not disclosed to non-employees except as approved in writing by the Director, Quality & Safety or appointed designate.
• Ensure that laboratory maintains good standing in appropriate check sample programs such as appropriate.  Respond quickly to questions concerning data quality.
• Maintain necessary document control including listing of currently used methods with accepted modifications clearly specified and records of method validation studies.
• Assist in assessing the level of occupational environmental/health/safety awareness of employees.
• Assist in the development and implementation of programs that will provide direction for occupational environmental/health/safety compliance.
• Assist in the review of all occupational injuries and illnesses to determine if the injury or illness is a recordable incident on the OSHA form.
• Assist in performing air contaminant sampling and occupational noise measurements.
• Maintain a perpetual state of readiness and willingness to respond to the queries and needs of clients, staff, and co-workers.
• Maintain cooperative working relationships with all company employees.  Communicate orally and in writing to co-workers.  This includes “intra” and “inter” departmental employees.

JOB QUALIFICATIONS:

• Bachelor’s degree in Science or related field, and 3 - 5 years related experience; or equivalent combination of education and work experience.
• Experience with occupational environmental/health/safety compliance required.
• Experience working in cGMP environment.