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QC Scientist III- Microbiology

Employer
Thermo Fisher Scientific
Location
Cincinnati, Ohio, US
Salary
Competitive
Closing date
Jan 31, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information:

Cincinnati, OH

What you will do:

Under the general direction of the microbiology supervisor or laboratory manager, oversees all aspects of raw material and finished product testing, method development, and general microbiology laboratory oversight. Leads efforts to develop and validate microbiological methods consistent with USP, JP, and Ph. Eur compendia procedures. Assists laboratory management with the alternate method development or validation to demonstrate equivalence to compendia methods, as appropriate. Provides daily bench support and oversight of junior personnel to ensure media batches are qualified, testing is completed in a timely manner, and adequate supplies of media or reagents are available. Supports laboratory management in interactions with client and/or regulatory inspections, as it relates to raw material or finished product testing and laboratory compliance. Assists with Trackwise investigations and GMP investigations as appropriate. With the laboratory supervisor / laboratory manager, provides back-up support/direction for the Environmental Microbiologist during vacations, illness, or similar occasions.

Essential Functions:
  • Schedules and completes microbiological testing of raw material, finished product, and stability samples using validated compendia methods.
  • Prioritizes testing to assure timely release to meet production and delivery timelines.
  • Plans, completes, and publishes method validation studies to demonstrate that test procedures satisfy compendia requirements and are appropriate to complete micropurity testing of raw material or finished products.
  • Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results.
  • Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.
  • Oversees junior staff to ensure proper training and execution of validated test methods.
  • Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.
  • Maintains and troubleshoots analytical instrumentation as needed.
  • Prepares and assists in filing regulatory documents in support of internal projects.
  • Provides communications with outside departments, corporate sites, agencies, and clients.
  • Writes SOPs and other instructional documents. Cleans and organizes work area, instrumentation, and testing materials.
  • Ensures instruments and procedures remain compliant and in a validated state of control.
  • Performs all duties in strict compliance with SOPs, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
  • Maintains the necessary compliance status required by company and facility standards.


How will you get here:

Education:

Bachelor's degree in biological or physical sciences, preferably Microbiology, Biology, or Biochemistry

Experience:

  • A minimum of 2 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples.
  • Experience with common office software is required and familiarity with relevant data acquisition systems a plus.


Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:
  • Demonstrated competency in laboratory skills a must.
  • An understanding of microbiological or biological systems and instruments / technologies is a plus. Good knowledge of qualitative and quantitative microbiological analysis and proficiency in aseptic techniques.
  • Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs.
  • Good problem-solving skills and logical approach to solving scientific problems.
  • Good interpersonal and communication skills (both oral and written).
  • Good presentation skills to present information to customers, clients, and other employees.
  • Ability to read, analyze, and interpret technical procedures and governmental regulations.
  • Ability to write standard operating procedures, protocols, and reports.
  • Ability to respond to common inquiries or complaints from customers or regulatory agencies.
  • Ability to apply mathematical operations to microbiological, biochemical, or analytical operations.


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 pound 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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary 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

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