Quality Specialist II

Job Description

<p><strong>Quality Specialist II</strong></p><p><br></p><p><em>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. </em></p><p><br></p><p><strong>Client:</strong> <em>Biotechnology company</em></p><p><strong>Contract/Perm & duration: </strong>12-month contract</p><p><strong>Location: </strong>Toronto</p><p>This position will be working 5 days onsite per week.</p><p><br></p><p><strong>Responsibilities:</strong></p><ul><li>Work with a team of internal and external quality specialists supporting the development and manufacturing of GMP cell and gene therapies</li><li>Work with team members to draft and review GMP documents including Standard Operating Procedures and other manufacturing and quality control documents.</li><li>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.</li><li>Perform reviews and approvals of manufacturing documentation</li><li>Perform raw material release and room release activities.</li><li>Quality Control and Manufacturing support and oversight</li><li>Participate in facility walkabouts, and internal and external audits.</li><li>Other duties as assigned.</li></ul><p><br></p><p><strong>Key Qualifications:</strong></p><ul><li>Bachelor’s degree in Biology or relevant scientific or engineering discipline</li><li>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</li><li>Experience with deviations, investigations, CAPA and change control and electronic quality management systems is desired</li><li>Must be detail-oriented with excellent organizational skills</li><li>Strong technical writing skills with working knowledge of MS office programs, such as Word, Excel, SharePoint, Access and Adobe Acrobat professional are required</li><li>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</li><li>Proven ability to identify quality issues and effectively and proactively resolve issues in a team setting</li></ul><p></p>