Proclinical is working closely with a well known Biotechnology organization who are seeking a Quality Control Scientist who will be responsible for conducting quality control testing in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The role also involves overseeing the work of junior QC staff, assisting with the management of the QC laboratory, and ensuring GMP compliance.
Establish, revise, and maintain procedures for QC testing.
Maintain QC systems related to in-process, final drug product, and stability sample.
Review testing data of other analysts.
Assist with the maintenance of QC laboratory and equipment.
Perform QC testing of raw materials, in-process, water, and product samples following SOPs.
Assist with audits and regulatory inspections, as needed.
Oversee sampling and storage of QC samples and maintain retain inventory.
Coordinate shipping of samples to Milton Park and contract testing laboratories.
Assist with training of others within the department within the scope of knowledge and responsibilities.
Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
Proficiency in computer literacy (including MS Word and Excel).
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.