Senior QC Specialist - Investigations (Biotech)
Apex Systems is a large staffing and consulting firm and we are looking for a Senior QC Specialist with experience in QC for investigation and documentation for biotech industry, strong knowledge of writing CAPAs, managing QMSs, cGMP documentation, and exposure to cell production or manufacturing facilities, for one of our biotech clients in Toronto.
- Client: Biotechnology company
- Contract/Perm \& duration: 12-month contract (possibility of extension/conversion)
- Location: Toronto
- This position will be working 5 days/week onsite
The Senior QC Specialist - Investigations will provide support to the Quality Control and Analytical Sciences (AS) and Manufacturing team for a wide variety of QC Compliance requirements, with a focus on leading Investigation and Non conformances, that may occur while testing cell-based therapeutics destined for human clinical trials. The Senior QC Specialist will be one of the key contributors in compliance excellence, driving all aspects of the QC laboratory compliance through appropriate quality systems. The candidate will report to the Senior Manager, QC Ops and work closely with the QC Testing, Ops and AS team to provide support in all quality aspects. The Senior QC Specialist will be instrumental in ensuring compliance within the laboratory through issue reviews, deviations, change controls, OOSs/OOTs, CAPAs, and audit support.
Responsibilities:
- Lead major lab investigations including cross-functional interaction/coordination with, but not limited to, QC functional groups, Manufacturing, Process Development and Supply Chain etc.
- Drive QC compliance by providing directions and support to the records owners under the following categories: issue reviews, deviations, change controls, OOSs/OOTs, CAPAs, and audit activities. Work closely with Quality Assurance (QA) to lead management of QC-related Quality Management System (QMS) activities relevant to release/stability testing of cell seeds, banks, intermediates, drug substance and drug products, method qualification/validation, equipment, and processes etc.
- Provide QMS platform support to QC and AS team and track/facilitate on time closure of all QMS events.
- Author and review SOPs related to QC activities and provide QC input for cross-functional SOPs relating to general GMP compliance.
- Support the development and maintenance of up-to-date training matrix for all QC personnel including test method proficiency training; work with QC management team to establish training strategies at a need basis to allow work flexibility across QC functional groups.
- Other duties and/or off-hours work may be assigned as needed.
Key Requirements:
- Minimum of a Bachelor's degree in Biological Sciences or related field with a minimum of 6 years of relevant experience in the industry is required OR a Master's degree with 4 years relevant experience is required.
- Experience in Quality Control within the Biotechnology setting is a must, strong preference particularly for experience in Cell therapies in a cGMP-compliant environment.
- Experience in the execution of elements within the quality system, including Issue Reviews, Deviation management, Change controls, OOS/OOT investigation, CAPA implementation and audit support.
- Excellent written and oral communication skills, with strong organizational skills, keen attention to detail and proven ability to be highly productive and successful in a high pace work environment.
- Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
