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QC Scientist II

Employer
Thermo Fisher Scientific
Location
Alachua, FL
Closing date
Nov 30, 2021

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Sector
Science, Pharmaceutical, Quality Assurance
Organization Type
Corporate
When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $30 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Located in Alachua, FL in the Quality Control Department of a dynamic gene and cell therapy contract development and manufacturing organization

How will you make an impact?

The QC Scientist II will work in the GMP compliant QC department to support GMP testing of biopharmaceutical products being manufactured at VVS under contract. The position includes performing routine lab activities such as cleaning, inventories, equipment preventive maintenance and calibrations, ordering supplies, and executing analytical assays. The Scientist will also develop, qualify and conduct assays including ddPCR, qPCR, ELISAs, SDS-PAGE, cell based assays including infectious titers, and chemistry based assays such as pH, osmolality, etc.

What will you do?
  • Qualify, perform, and evaluate the results of cell viability, infectivity assays including TCID50, ddPCR/qPCR assays, Western blot assays, ELISAs, and other assays related to the safety and release testing of intermediate and final biological products. These assays must be performed according to written procedures and in compliance with cGMP regulations.
  • Maintain complete, contemporaneous and accurate records of all work performed. Maintain equipment records as required by written procedure. Write planned variances, deviation reports, track data and write reports in compliance with cGMPs. Assist with document revisions for SOPs and Test Records.
  • Other assigned duties include handling reagents and material supply, maintaining equipment via cleanings, calibrations and preventive maintenance. Maintaining appropriate in-house assay standards including inventory and databases with other duties as assigned by supervisor. Ability to develop PM/Calibration programs on simple equipment.
  • Ability to initiate and assist in investigations for invalid assays or similar

How will you get here?
  • A Bachelor's Degree or higher in an appropriate area of specialization.
  • A minimum of three years of meaningful work experience with preference for candidates that have previously worked in a cGMP compliant QC laboratory performing biological assays such as those listed above.
  • Strong aseptic technique, with focus on cell-based assays and cell line maintenance, including cell bank generation and cell line thaw. Must have experience with both adherent and suspension cell lines.
  • Ability to read, interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals with the ability to use the information to build job specific standard operating procedures
  • Laboratory documentation, reports, and correspondence

Knowledge, Skills, Abilities
  • Expertise in at least one relevant, non-compendial analytical or cell-based assay.
  • Skilled with electronic information management systems (LIMS, electronic lab notebooks, etc) and electronic organizational skills using Microsoft Excel, Smartsheet or other planning tools
  • Ability to communicate/work in a high pressure/high paced environment
  • Ability to multi-task and function optimally as a member of a team and perform tasks within the lab without direct supervision and then train others on procedures.

Analytical assays performed would support GMP manufacturing activities and release testing. This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.

At Thermo Fisher Scientific, each one of our 80,000 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.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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