Job Description
Quality Specialist II
Apex Systems is a large staffing and consulting firm and we are looking for a Quality Specialist II with experience with CAPA, working in a GMP environment on floor, some knowledge of QMS, and working with batch/release records for one of our biotech clients in Toronto.
Client: Biotechnology company
Contract/Perm & duration: 12-month contract
Location: Toronto
This position will be working 5 days onsite per week.
Responsibilities:
- Work with a team of internal and external quality specialists supporting the development and manufacturing of GMP cell and gene therapies
- Work with team members to draft and review GMP documents including Standard Operating Procedures and other manufacturing and quality control documents.
- Assist in Quality Investigations by coordinating OOS and Deviation investigations and executing CAPA procedures including facilitating identification of root cause, risk assessments and implementing corrective actions with monitoring for effectiveness.
- Perform reviews and approvals of manufacturing documentation
- Perform raw material release and room release activities.
- Quality Control and Manufacturing support and oversight
- Participate in facility walkabouts, and internal and external audits.
- Other duties as assigned.
Key Qualifications:
- Bachelor’s degree in Biology or relevant scientific or engineering discipline
- 2+ years of hands-on experience in a quality role within a regulated life sciences environment (biotechnology/pharmaceutical/medical device) is required; previous experience with biologics is highly desired
- Experience with deviations, investigations, CAPA and change control and electronic quality management systems is desired
- Must be detail-oriented with excellent organizational skills
- Strong technical writing skills with working knowledge of MS office programs, such as Word, Excel, SharePoint, Access and Adobe Acrobat professional are required
- Must be self-motivated with the demonstrated ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple, potentially changing, priorities
- Proven ability to identify quality issues and effectively and proactively resolve issues in a team setting
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