FSP-REMOTE QC Reviewer/ Senior QC Reviewer
FSP-REMOTE QC Reviewer/ Senior QC Reviewer
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Thermo Fishers 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.
Summarized Purpose:
Ensures the quality of laboratory data reports and systems. Reviews analytical data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods client criteria Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP). Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation. Provides expertise to the laboratory and quality groups in one or more specialized areas such as chromatography microbiology method validation or other applicable areas.
Essential Functions:
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.
Education and Experience:
Bachelors 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.
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:
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
Required Experience:
Senior IC
Employment Type
Full-Time
