Quality Assurance Associate

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 responsibilities will include:

• Rotating Shift work. 12 hour shifts, two weeks of days followed by two weeks of nights

• ​Provide consultation or advice in alignment with Quality Assurance (QA) policies through on the floor presence, working with other departments by providing QA guidance to events or questions that may arise

• Oversee active operations on the floor to ensure patient safety is achieved and to ensure that GMP, GDP, and Quality Management Systems are followed

• Support the incident program (Deviation, Laboratory Investigation, CAPA, etc.) including reviewing, assessing the severity, and approving minor incidents and outcomes of Phase 1 investigations

• Participation in the internal audit program and support external audit requirements

• Monitoring and enforcement of GMP principles during day-to-day operations

• Perform quality inspection and release of clean rooms

• Support document control programs

• Perform in-process Quality Inspections as required

• Support process lifecycle by creating or reviewing documents and change controls

Qualifications

Required:

• Bachelor's degree in a scientific field

• GMP experience

Desired:

• Experience in a Pharmaceutical Environment

• Experience with quality investigations

• Experience with document review

• CAPA experience

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:

No

Shift:

Swing

Duration:

No End Date

Job Function:

Quality/Regulatory