Quality Events Specialist

Job Description BIOVECTRA, now a part of Agilent, is recognized as a leader in the contract development and manufacturing space 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 both the Windsor, NS and Charlottetown, PEI sites, BIOVECTRA supports over 100 clients, including over 20 top pharma and biotech companies. BIOVECTRA joined Agilent in 2024 and is part of Agilent’s Advanced Manufacturing Partnerships Division (AMPD), which also contains Agilent’s Nucleic Acid Solutions Division. With BIOVECTRA, Agilent aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence. Within AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advanced manufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics. The Quality Events Specialist performs and coordinates quality events records, investigations for manufacturing deviations, events, environmental excursions, and process issues related to Windsor biologics operations. The role partners with Manufacturing, Quality, Engineering, QC, and MS&T to identify true root causes and implement CAPAs that prevent recurrence. Key Responsibilities: Lead investigations using structured tools: RCA, 5-Why, fishbone, fault tree, data analysis, and interviews Assess product and equipment impact for deviations and contamination events Develop and document CAPAs, evaluating their effectiveness over time Analyze trends to support continuous process improvement Support change controls and revision of technical documentation (SOPs, batch records, forms) Participate in internal/external audits as the investigation SME Support cleanroom and contamination-related investigations, including personnel flow, material movement, gowning, and hygiene compliance Ensure safe, compliant operations consistent with Health Canada, FDA, EMA, and corporate standards Qualifications Required: Bachelor’s degree in Science, Engineering, Biotechnology, or related field GMP manufacturing or quality experience, preferably in biologics. Desired: Strong technical writing skills and ability to lead cross-functional teams Working knowledge of RCA tools and investigation methodologies Understanding of aseptic behavior, environmental monitoring, and utilities preferred Ability to manage multiple priorities and meet disposition-critical timelines Proficiency with MS Office; experience in MasterControl, TrackWise, Veeva, or other QMS systems preferred Additional Details This job has a full time weekly schedule. The full-time equivalent pay range for this position is $66,514.00 - $103,928.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations 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. Travel Required: Occasional Shift: Day Duration: No End Date Job Function: Quality/Regulatory

The specialist coordinates quality event records and investigations for manufacturing deviations and environmental excursions. They partner with cross-functional teams to identify root causes and implement CAPAs to prevent recurrence.

A Bachelor's degree in Science, Engineering, or Biotechnology is required along with GMP manufacturing or quality experience. Proficiency in RCA tools and QMS software like MasterControl or TrackWise is preferred.

• Bonus • Stock • Benefits

• Analyse de donnéesSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Root Cause Analysis
• CAPA
• Technical Writing
• GMP Manufacturing
• Aseptic Behavior
• Environmental Monitoring
• Quality Management Systems
• Data Analysis
• Cross-functional Leadership
• Audit Support
• Change Control
• Deviation Investigation
• TrackWise
• Veeva
• Active Pharmaceutical Ingredients
• Cross-Functional Team Leadership
• Health and Hygiene Compliance Management
• Small Molecules
• Nucleic Acids
• Fermentation
• Advanced Manufacturing
• Aseptic Processing
• Biotechnology
• Biopharmaceuticals
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Continuous Improvement Process
• Fault Tree Analysis
• External Auditing
• Innovation
• Internal Auditing
• Local Number Portability
• MRNAs
• Operational Excellence
• Operations
• Pharmaceuticals
• Technical Documentation
• Investigation

• Manufacturing
• Science & Research
• Engineering
• Healthcare
• Security & Safety
• Special Events Specialist
• Unclassified Specialized Occupation

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine