How will you make an impact?
Provide moderately sophisticated analyses in a microbiology lab environment within defined procedures and practices. Perform analytical methods for moderately sophisticated 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; recommend solutions.

What will you do?

• Conduct moderately sophisticated microbiological testing of in process products and finished products by internally developed and compendial test methods.
• Perform validated test methods for in process products, and finished products 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 interact 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 Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains 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

3-4 years of experience performing tests or analyses for pharmaceutical raw materials, 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 Organizational Skills
Highly organized, thorough 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.

Core Proficiencies:
Put the Customer First - Think and act with a customer-centric mentality to deliver outstanding customer experiences.

Own Your Results - Take personal accountability for all you do and always exercise good judgement.

Find a Better Way Everyday - Be intellectually curious and embrace Practical Process Improvement (PPI).

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.

At Thermo Fisher Scientific, each one of our 120,000+ outstanding minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex,
Sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.