Quality Events Specialist

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 $ - $ 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 : 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 : Manufacturing