QC Technician II

3 weeks ago

Middletown, United States Thermo Fisher Scientific Full time

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materialsJob DescriptionAn opportunity exists for an experienced Quality Control Laboratory Technician I in the Clinical Diagnostics Division (CDD) of Thermo Fisher Scientific. This position offers the right candidate a key position in the Clinical Diagnostics Reagents (CDR) Quality Control Laboratory and will provide opportunities for career development and growth. The position resides in Middletown, Virginia.The Clinical Diagnostics Reagents (CDR) delivers In-vitro Diagnostic products for large diagnostic companies in support 10 Billion clinical tests annually. These tests help with Cancer screening, assist in managing Cardiac disease and reduce the impact of Sepsis in hospitalized patients.The CDR Quality Control Laboratory ensures our products and solutions are safe, reliable, and meet Clinical Standards.How will you make an impact:Perform laboratory testing and release/rejection of raw materials, intermediates and finished products applying clinical chemistry, immunoassay, analytical and microbiological methods, and automated systems for testing at the Middletown site. Assure technical correctness of all testing/value assignment functions to ensure products align with established internal and external requirements required to maintain consistent product performance and quality in the field.What will you do:
Performs laboratory analysis on products for the purpose of Releasing product, Assessing stability. Effecting raw material release, Supporting other technical service groups
Prepares specimens for testing and tests and releases product in accordance with written test procedures.
Schedules testing to meet department and plant commitments.
Maintains instrumentation/equipment in alignment with manufacturer's labeling and in-house audit and calibration procedures.
Leverage GMP in Maintaining records and logs.
Maintains working laboratory inventory.
Other laboratory functions required to support business needs.

How will you get here:Associates degree in Biology, Chemistry, Medical Technology, or related fieldExperience:
2 plus year of laboratory experience
Experience in Analytical Chemistry, Immunoassay, Hematology, Coagulation, Microbiology or Clinical Chemistry.

Knowledge, Skills, Abilities:
Prioritize work ensuring scheduled commitments are achieved.
Ability to troubleshoot problems with limited assistance.
Must be flexible and able to work overtime
Develop good working relationships with all departments and occasional contact with outside sources
Knowledge of GMP and ISO requirements
Microsoft Office (Word and Excel) required
Demonstrate the Thermo Fisher values (The Four I's) - Integrity, Intensity, Innovation, and Involvement

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