QC Scientist II - Microbiology at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor’s degree in Biology or Chemistry preferred; Associate degree in Biotechnology or science concentration minimally required (with industry experience considered for Associate degree)
3+ years related experience in a Pharmaceutical Microbiology laboratory or related experience
Experience with LIMS, SLIM, Trackwise, or Documentum a plus; experience as a reviewer, approver, or qualified checker preferred
Highly organized, meticulous, and self-motivated
Adaptable and capable of working within a team as well as independently
Knowledge and understanding of the scientific approach to microbiological methods development and validation
Knowledge of qualitative and quantitative microbiological tests
Awareness of quality and regulatory requirements in the pharmaceutical industry
Ability to write standard operating procedures and method validation reports
Ability to read and interpret technical procedures and governmental regulations
Ability to apply mathematical operations to different testing designs
Problem-solving and interpersonal skills
Core proficiencies: Put the Customer First (think and act with a customer-centric approach); Own Your Results (take personal accountability)

Responsibilities

Conducts moderately sophisticated microbiological testing of in-process products and finished products by internally developed and compendial test methods
Performs validated test methods for Bioburden, Microbial Examination Testing, Identification of Organisms, and Growth Promotion Testing
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
Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and acquired results; records and reports results 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 prioritizes work area, instrumentation, and testing materials; maintains stock of commodities needed for testing support
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines; maintains vital compliance status required by company and facility standards

Skills

Microbiology

Bioburden Testing

Microbial Examination

Organism Identification

Growth Promotion Testing

GMP

Analytical Methods

Instrumentation Troubleshooting

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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