Scientist I, Quality Control

Replimune•Framingham, MA

12d•$112,500 - $146,000•Onsite

About The Position

The Scientist I/II, QC Analytical will perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). This role may also include the responsibility of overseeing the work of junior QC staff and provide training for new analyst. The QC Analytical Scientist will be responsible for assisting with maintaining systems for QC Analytical Laboratory. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs). The QC Analytical Scientist will assist in the management of the QC laboratory. It is expected that the QC Scientist will maintain GMP compliance in the QC laboratory. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

BA or BS in analytical chemistry or other related science, preferably with chemistry or coursework as part of the study program.
5+ years of experience working in GMP/GLP environment or similar set up.
Knowledge of Analytical techniques and technical experience, within a Analytical Lab is preferred.
Computer literacy (MS Word and Excel), good communication and organizational skills.
Ability to work well independently and with others in a team.
Good organizational skills

Responsibilities

Establish, revise and maintain procedures for QC Analytical testing.
Maintain QC systems related to raw materials, in-process, drug substance and final drug product sample testing.
Review testing data of other analysts.
Assist with the maintenance of QC laboratory and equipment.
Responsible for the protocol and report generation of method qualifications related to QC tests.
Perform QC Analytical testing of raw materials, in-process, water and product samples following Standard Operating Procedures (SOPs).
Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
Responsible for change control, deviations and CAPA’s related to QC Analytical operations including conducting OOS, OOT, and lab investigations.
Assist with audits and regulatory inspections, as needed.
Assist with QC laboratory equipment validation.
Interact within internal, as well as across other functional groups to communicate QC Analytical requirements.
Oversee sampling and storage of QC samples and maintain regulatory/retention inventory.
Coordinate shipping of samples to contract testing laboratories.
Train of others within department within the scope of knowledge and responsibilities.
Understanding of USP/EP monograph testing/requirements.
Troubleshoot equipment and analytical test methods.
Manage technical studies performed with external companies with provision and review of reports.
Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
Other tasks as assigned.