How will you make an impact?

Provide moderately challenging analyses in a microbiology lab environment within defined procedures and practices. Perform analytical methods for moderately complicated testing on raw materials, samples, stability, and production intermediates. Support internal development and/or manufacturing operations. Make detailed observations and reviews, documents, and communicates test results; recommends solution. Typical hours for this role is 8:00a - 4:30p, Monday through Friday, but will require flexibility for occasional earlier starts, staying later, and weekend work.

What will you do?

• Conduct moderately challenging microbiological testing of in process products and finished products by internally developed and compendial test methods.
• Perform validated test methods for Bioburden, Bacterial Endotoxin Testing, Particulate Matter, Sterility, and Water testing.
• Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.
• Maintain and troubleshoot analytical instrumentation as needed.
• Clearly and accurately communicate the results of work by crafting documentation of the testing/analysis and acquired results. Record and report results of analysis in accordance with prescribed lab procedures and systems. May work with clients.
• Prepare and assist in filing regulatory documents in support of internal projects. Provide communications with outside departments, corporate sites, agencies, and clients.
• Write SOPs and other instructional documents.
• Clean and coordinate work area, instrumentation, and testing materials.
• Maintain stock of commodities needed for testing support.
• Perform all duties in strict compliance with Protocols, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the vital compliance status required by company and facility standards.

How will you get here?

Education

Bachelor preferred - preferably with Biology or Chemistry concentration.

Associate degree required - preferably in Biotechnology or science concentration.

Equivalent combinations of education, training, and meaningful work experience may be considered if an Associate degree is acquired

Experience

Up to 2 years of experience performing tests or analyses for pharmaceutical raw material, in process product, and finished product samples.

Experience with common office software and data acquisition systems.

Experience with LIMS, SLIM, Trackwise, or Documentum a plus.

Experience as a reviewer approver or qualified checker preferred.

Knowledge, Skills, Abilities

Good problem-solving skills and logical approach to solving scientific problems.

Good interpersonal and communication skills (both oral and written- legible handwriting).

Good presentation skills to present information to customers, clients, and other employees.

Strong Mathematical and Time Management Skills

Good Interpersonal Skills

Highly organized, detailed and self-motivated

Good knowledge and understanding of microbiological methods and aseptic technique.

Good knowledge of quality and regulatory requirements in the pharmaceutical industry.

Ability to read, analyze, and interpret technical procedures and governmental regulations.

Ability to write standard operating procedures, simple protocols, and reports.

Ability to respond to common inquiries or complaints from customers or regulatory agencies.

Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.

Adaptable and Capable of working within a team as well as independently

Knowledge of qualitative and quantitative microbiological Tests.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

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