QA Associate (Document Review)

Job#: 2021060

Job Description:

QA Associate (Document Review)

Apex Systems is a large staffing and consulting firm and we are looking for a QA Associates with experience with QA documentation review, exposure to GMP/GDP, and a background in life sciences for one of our biotech clients in Toronto. 

Client: Biotechnology company

Contract/Perm & duration: 6-month contract (possibility of extension/conversion)

Location: Toronto

This position will be working 100% on-site as it is required for daily responsibilities 

Responsibilities:

• Reviewing executed batch records and equivalent production documents, as well as assisting in closure of batch record review backlog
• Supporting day-to-day operations such as room release and reviewing manufacturing and equipment changeover activities
• Reviewing quality events, including deviations, lab investigations, CAPAs, and change controls
• Supporting document reviews, including but not limited to SOPs, COAs, protocols, and reports
• Working closely with both Manufacturing, Quality Control, and Facilities teams in any quality matter
• Responsible for performing quarterly walkabouts, following up on the observations, and supporting 5S excellence projects
• Supporting various process improvement projects, contributing to the overall success of the GMP operations at MaRS7 and PMCRT-15 (Toronto GMP Sites

• Undergrad or master’s degree in biological sciences, analytical chemistry, chemical engineering, biomolecular engineering, microbiology, or similar
• 1-2 years experience in GMP industry (junior level)- Any experience in biotechnology industry is preferred but not required
• Strong knowledge on GMP and GDP
• Strong critical thinking skills when working on new procedures or process improvements
• Strong teamwork and communication skills
• Strong written and verbal communication skills and efficient in communicating to inter-disciplinary and cross-functional team
• Detail-oriented individual with a passion for quality and a strong desire to contribute to a dynamic team
• Proactive and able to work in a fast-paced team environment while prioritizing tasks for multiple projects
• Familiar with electronic document and quality management systems (preferred but not required)

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.