Quality Events Specialist

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

Required:

• Bachelor’s degree in Science, Engineering, Biotechnology, or related field

• GMP manufacturing or quality experience, preferably in biologics.

• 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