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.