QA Associate

3 days ago

Charlottetown, Prince Edward Island, Canada Agilent Technologies Full time
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 Assurance Associate will performs a wide variety of activities to ensure manufacturing and production are in compliance with applicable Agilent and regulatory requirements by conducting audits, training programs, data and documentation reviews and analysis and product disposition.

Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation relating to compliance with internal and external safety, quality, and regulatory standards.

Implements and maintains quality assessments for change notices/orders, investigations and corrective/ preventative actions.

Provides timely updates and follows up on open issues of all assigned changes, investigations and corrective/ preventative actions.

Coordinates the interaction between engineering, manufacturing, field operations and marketing to ensure appropriate changes, investigations and corrective/preventative actions are documented.

Performing batch record review and data review for release of critical raw materials, active pharmaceutical ingredients, and final products.

Qualifications

Bachelor's or Master's Degree or equivalent.

1+ years relevant experience.
 

Additional Details

This job has a full time weekly schedule.The full-time equivalent pay range for this position is $58, $91,838.00/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: 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: NoShift: SwingDuration: No End DateJob Function: Quality/Regulatory

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