Quality Events Specialist, Cobequid Bay north shore (Springhill)
Quality Events Specialist, Cobequid Bay north shore (Springhill)
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Cobequid Bay north shore (Springhill) B0M, Canada
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Last edited: less than a week ago
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Description
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. Within AMPD, you will have the opportunity to work with cutting‑edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advancedmanufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics.
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 Qualifications
Bachelor’s degree in Science, Engineering, Biotechnology, or related field
GMP manufacturing or quality experience, preferably in biologics.
Desired Qualifications
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 $27.59 – $48.29/hr 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: 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
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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 Qualifications
Bachelor’s degree in Science, Engineering, Biotechnology, or related field
GMP manufacturing or quality experience, preferably in biologics.
Desired Qualifications
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 $27.59 – $48.29/hr 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: 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
#J-18808-Ljbffr
Highlights
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Company nameAgilent Technologies
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Job positionQuality Events Specialist
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