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Associate QC Reviewer

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Summarized Purpose:
Ensures the quality of laboratory data and reports. Assists with reviewing chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs). May evaluate data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).

Essential Functions:
  • Evaluates laboratory data for compliance with analytical methods and SOPs.
  • Reviews sample results for completeness and accurate representation of the data and report findings.
  • Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.
  • Communicates with laboratory staff to proactively address the quality of laboratory documentation.
  • Performs other duties as assigned.

Qualifications - External

Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years’) or equivalent combination of education, training, & experience.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
  • Knowledge of SOPs and Federal Regulations to include GLP and GMP
  • Knowledge of chromatography and divisional SOPs
  • Verbal and written communication skills
  • Attention to detail
  • Ability to deal with multiple and changing priorities
  • Ability to provide clear and concise feedback and/or documentation of results
  • Ability to work in a collaborative team environment

As a condition of employment with PPD, part of Thermo Fisher Scientific, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

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CEO of Thermo Fisher Scientific
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Marc N. Casper
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Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing ...

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DATE POSTED
June 9, 2023

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