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Description
Job Description
Summary:
Provides moderately complex analyses in a microbiological environment within defined procedures and practices. Performs microbiological methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or method development testing. Supports internal development and/or manufacturing operations. Makes detailed observations, reviews documents, and communicates test results; recommends solutions.
Essential Functions:
Conducts moderately complex microbiological testing of pharmaceutical raw materials, packaging components, finished products, and stability samples by internally developed and compendial test methods.
Completes Microbiology Method Development Protocols that are written internally by Microbiology Management and signed off with QA and Client approval.
Recognizes and reports out-of-specification or unexpected results and non-routine product problems; recommends solutions.
Maintains and troubleshoots analytical instrumentation as needed.
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.
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.
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
Education:
Bachelor's degree (required) in physical science, preferably in Chemistry or Biology.
Experience:
Minimum of 2 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. Experience with aseptic technique and common office software..
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
Experience with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Proficient in the understanding and application of aseptic technique, environmental monitoring, and identification of microorganisms. Effective written and interpersonal skills with the ability to interact with Auditors if there is a need. Strong proficiency in Microsoft Office Suite (Word, Excel, and Power Point). Ability to multitask by working on multiple projects simultaneously, and able to adapt and change priorities when business needs demand a shift in priority. Ability to work weekends when needed based on business needs.
REQUIRED:
- Good knowledge and understanding of analytical instrumental technologies.
- Good knowledge of qualitative and quantitative microbiological analysis.
- 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.
- Proficiency with Environmental Monitoring, Microbial Limits Testing, Growth Promotion, Media Quality Control, and Method Development (preferred).
- 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, 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.
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.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
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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.
