Quality Assurance Associate

Agilent Technologies

4d•$24 - $43

About The Position

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

Requirements

Bachelor's degree in a scientific field
GMP experience

Nice To Haves

Experience in a Pharmaceutical Environment
Experience with quality investigations
Experience with document review
CAPA experience

Responsibilities

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