16 Oct
|
Agilent Technologies
|
Montague
16 Oct
Agilent Technologies
Montague
Job DescriptionBIOVECTRA, now a part of Agilent, is a leader in contract development and manufacturing of active pharmaceutical ingredients, specializing in clinical-to-commercial scale production for microbial fermentation, synthetic small molecules, including ADC, HPAPI, plasmid DNA, mRNA, LNP and sterile filling capabilities. With over 650 employees at Windsor, NS and Charlottetown, PEI, BIOVECTRA supports more than 100 clients, including over 20 top pharma and biotech companies.Agilent is currently searching for a Quality Assurance Training Lead. This role focuses on designing and implementing QA training programs that align with safety, regulatory standards, and business goals. Responsibilities include enhancing staff competency by identifying skill gaps and creating targeted learning plans. Training programs must align with applicable regulatory requirements including Health Canada GUI-0001, 21 CFR 211.25, ICH Q10, and applicable GMP standards.ResponsibilitiesPartner with functional areas to conduct ongoing needs analysis, training effectiveness checks, and trend analysis.Apply knowledge of Health Canada, FDA, and ICH Q10 regulatory expectations for personnel training and qualification.Manage LMS or equivalent electronic training management system.Serve as the primary training system representative during regulatory inspections.Partner with global training and quality leadership to ensure alignment of site training practices with enterprise-wide standards and governance frameworks.Coordinate training program execution across multiple BioVectra sites (PEI and Windsor).Establish and maintain a trainer qualification program.Develop training materials and knowledge assessments for area SOP reviews.Collaborate with functional departments to draft, implement, approve, and revise training materials.Facilitate or support instructor-led training courses, including annual cGMP training.This role has the option of working onsite at our Windsor, NS or Charlottetown, PEI facility.QualificationsRequiredPost-secondary education.Prior experience in a GMP-regulated quality setting.Four years of relevant experience and/or training and management of teams within a biotech or pharmaceutical environment.Exceptional facilitation and presentation skills.Experience with quality systems.DesiredTrain the Trainer Certification.API facility experience.Knowledge of Rise Articulate platform.LMS experience.DesiredKnowledge of metrics/trending.Additional DetailsFull-time position with a weekly schedule. Pay range $81,022.00 - $126,596.00 CAD per year, plus eligibility for bonus, stock, and benefits. Pay and benefit information by country is available at https://careers.Agilent.Com/locations. Travel required: 10% of the time. Shift: Day. Duration: No end date. Job function: Quality/Regulatory.Agilent Technologies Inc. is an equal-opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.#J-18808-Ljbffr
📌 Quality Assurance Training, Lead Agilent Technologies - C$81,022 - C$126,596 A Year (Montague)
🏢 Agilent Technologies
📍 Montague