This job board retrieves part of its jobs from: Toronto Jobs | Emplois Montréal | IT Jobs Canada

Showing you new job offers everyday

To post a job, login or create an account |  Post a Job

Quality Control Project Specialist

Rentschler Biopharma

This is a Full-time position in Milford, MA posted April 8, 2021.

Job SummaryThe project QC Project Specialist organizes the actives as it relates to client project delivery, client support and implementation of activities from the QC teamDuties and ResponsibilitiesContact for the complete analytical methods portfolio and link between project team, international customers and laboratoryProject planning of analytical work packagesOrganizational and technical support of analytical method developments in the context of projectsCoordination of analytical support and coordination of timelines between development and production departments and the laboratory Inter-laboratory compilation, evaluation and documentation of various analytical data as well as collaboration in the lifecycle management of analytical methods Representation of the analytics in assigned projects towards the project team and international customers Assistance with approval documents and requests from authorities Continuous research for new methods/techniques as well as initiation and organization of laboratory testing Perform equipment maintenance and calibrations as required.Ensure department readiness for audits by both internal and external authorities.

Serve as the Quality Management backup person for the lab, and interface with investigators during both internal and external inspections.Perform and/or supervise validation of analytical methods per ICH USP guidelines, experience authoring SOP’s, investigations, deviations and change controls.Assess new projects as it relates to QC activities and capabilitiesQualificationsB.S.

in biotechnology or related scientific discipline (master’s degree preferred)10+ years of Quality Control experience in a cGMP biologics environment or master’s degree and 8+ years of related experience Relevant experience with project management and method implementation requiredStrong Understanding of GMP’s with expectations of a commercial GMP environmentMust communicate effectively (verbal and written) with director and peers.

 Written communicate skills require full competence in following detailed written instructions, creating/revising SOP’s and reportsAdvanced knowledge development, approval, manufacturing and testing of biopharmaceuticals  Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint and ProjectWorking ConditionsLaboratory environment working with chemical reagents and analytical equipmentPersonal Protective Equipment must be worn as required.Normal office working conditions: computer, phone, files, fax, copier.Will interact with other people and clientsPace may be fast and job completion demands may be high.

 Physical RequirementsFrequent lifting up to 10 lbs.Frequent standing/walking to work in lab environment for extended periods.Frequent sitting for extended periods to use computer.Direct Reportsn/a