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FSP-REMOTE QC Reviewer/ Senior QC Reviewer
About the position
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. As a Senior QC Reviewer you will perform a variety of complex analytical review for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. You will help coordinate and maintain different quality systems and be expected to weigh in on quality matters within the team. This position is focused on Large Molecule: ELISA, HPLC, CE-SDS, cIEF, SPR, and qPCR.
Responsibilities
- Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.
- Validates large and/or non-routine projects.
- Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.
- Reviews sample results for completeness and accurate representation of the data and reports findings.
- Provides expert knowledge in one or more analytical techniques (ELISA, HPLC, CE-SDS, cIEF, SPR, and qPCR) to assist laboratory and quality groups make informed decisions.
- Communicates with laboratory staff to proactively address the quality of laboratory documentation.
- Prepares QC statements noting deficiencies with the analytical data set or notebooks.
- Reports deficiencies to the project leader for correction.
- Trains new QC Reviewers and laboratory staff.
- Assists the departmental manager or supervisor in the evaluation of the laboratory QC program.
- Helps maintain compliance and assists in continuous improvement of laboratory processes.
- Performs other duties as assigned.
Requirements
- 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 2+ years') or equivalent combination of education, training, & experience.
- Expert knowledge of SOPs and Federal Regulations to include GLP and GMP.
- Expert knowledge of chromatography or other applicable analytical techniques and divisional SOPs.
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards.
- Strong verbal and written communication skills.
- Strong attention to detail.
- Ability to train staff.
- 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.