QC Reviewer - Laboratory services
Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Fargo, ND; Kansas City, KS and Seattle, WA.
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to
achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.
The QC Reviewer is responsible for performing daily in-process quality control on various projects. Ensures that all project related documentation is filled out accurately and in a timely manner by the analysts and that all procedures are respected as per the company's SOPs.
Performs daily in-process quality control on multiple projects inter-team;
Verifies forms/paperwork and data tables generated by the analysts;
Ensures that Health and Safety standards in terms of personal protection, laboratory maintenance, work procedures and ergonomics are respected;
In charge of the quality within the laboratory according to GLP, regulatory agencies requirements and internal SOPs;
Supports and mentors analysts during the generation of supplementary information forms as needed to ensure documentation accuracy and completeness;
Ensures harmonization of techniques, procedures and documentation between analysts in the laboratory;
Conducts all work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies;
May respond to in-life QA report;
May perform process verification audits: develops, executes and reports.
College degree and/or University degree in Biochemistry, Immunology or equivalent field.
Experience in the medical and/or pharmaceutical fields with typically 2 years of experience in data review and quality control field. Must understand general SOPs and have knowledge of GLP regulations.
Skills: Good organizational, attentive to details with respect to sample pre-treatment procedures and raw data handling, good communication, able to work with different teams. Good leadership.
Software: MS-Office, Outlook, Random, Analyst, BX System, Validation, Dosage, Labeler.
- Everett, WA, USA