Senior QC Specialist - Investigations (Biotech)

Apex Systems; Toronto; On-site; CAD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Senior QC Specialist to join their dynamic team in Toronto. This exciting role involves leading QC investigations and ensuring compliance in a fast-paced biotech environment. The ideal candidate will have extensive experience in managing quality systems, writing CAPAs, and supporting laboratory compliance for cell-based therapeutics. With a focus on collaboration and communication, this position offers the opportunity to make a significant impact on clinical trial testing processes. If you are passionate about quality assurance and thrive in a challenging environment, this role is perfect for you.

Qualifications

• 6+ years of experience in QC investigations within the biotech industry.
• Strong knowledge of CAPAs and managing QMS in a cGMP environment.

Responsibilities

• Lead major lab investigations and coordinate with various teams.
• Drive QC compliance through issue reviews, deviations, and audits.

Skills

QC investigations

CAPA writing

Quality Management Systems (QMS)

cGMP documentation

Communication skills

Organizational skills

Attention to detail

Education

Bachelor’s degree in Biological Sciences

Master’s degree in Biological Sciences

Tools

Microsoft Office Suite

Job description

Senior QC Specialist - Investigations (Biotech)

Apex Systems is seeking a Senior QC Specialist with experience in QC investigations and documentation within the biotech industry. The ideal candidate will have strong knowledge of writing CAPAs, managing QMSs, cGMP documentation, and exposure to cell production or manufacturing facilities. This role is for one of our biotech clients in Toronto.

Contract/Perm & Duration: 12-month contract (possibility of extension/conversion)

Location: Toronto

*This position requires onsite work 5 days/week*

The Senior QC Specialist will support the Quality Control and Analytical Sciences (AS) and Manufacturing teams in QC compliance, focusing on investigations and non-conformances related to testing cell-based therapeutics for human clinical trials. The role involves ensuring laboratory compliance through issue reviews, deviations, change controls, OOSs/OOTs, CAPAs, and audit support. The candidate will report to the Senior Manager, QC Ops, and collaborate closely with QC Testing, Ops, and AS teams.

Responsibilities:

1. Lead major lab investigations, coordinating with QC, Manufacturing, Process Development, and Supply Chain teams.
2. Drive QC compliance by supporting records owners in issue reviews, deviations, change controls, OOSs/OOTs, CAPAs, and audits. Collaborate with QA to manage QC-related QMS activities relevant to cell seed release, stability testing, method validation, equipment, and process qualification.
3. Support QMS platform activities for QC and AS teams, ensuring timely closure of all QMS events.
4. Author and review SOPs related to QC activities and contribute to cross-functional SOPs ensuring GMP compliance.
5. Develop and maintain training matrices for QC personnel, including test method proficiency training, and establish training strategies for flexible work arrangements.
6. Perform other duties or off-hours work as needed.

Key Requirements:

1. Bachelor’s degree in Biological Sciences or related field with at least 6+ years of relevant experience, or Master’s degree with 4+ years of relevant experience.
2. Experience in Quality Control within the biotech setting, preferably in cell therapies within a cGMP environment.
3. Proficiency in quality system elements such as issue reviews, deviation management, change controls, OOS/OOT investigations, CAPA, and audit support.
4. Excellent communication, organizational skills, attention to detail, and ability to work effectively in a high-paced environment.
5. Computer skills with familiarity in Microsoft Office suite.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Science, Quality Assurance, and Research

Industries: Research Services, Chemical Manufacturing, Biotechnology Research