Description
Augurex Life Sciences Corp, hiring within the Biotech / Medtech industry, has an immediate opening for a Manager, Quality Assurance. Augurex is a growing company that has a dynamic, cohesive team of employees who are passionate about bringing our products to market. Our team is driven to positively impact the world through improving the quality of the lives of patients who benefit from our products. If you are a self-motivated team-player who thrives in a rapidly evolving organization and embraces a culture of growth and change, we would love to hear from you!
Summary
We: 1) are passionate about health, 2) have a positive attitude, 3) operate with a sense of urgency, and 4) consider no problem unsolvable. If your personal values are aligned with our core values, and your skills and qualifications fit the list below, this is an opportunity for you.
The Manager, Quality Assurance is a cross-functional team member responsible for a range of priorities related to Augurex’s existing and new products. These include reviewing and approving production records, spearheading the selection and first-time implementation of an eQMS (electronic Quality Management System) in 2023, and handling administrative tasks related to maintaining and retrieving quality records. This individual will possess exceptional communication skills, have a keen eye for detail, and be able to plan and prioritize effectively during high and low-volume work periods. The ideal candidate will thrive in a fast-paced, high-performing, collaborative environment and be comfortable with process ambiguity. They will develop and implement strategies for quality improvement and will be looking for a chance to evaluate complex problems within the biotechnology sector.
Role And Responsibilities
- Independently review and approve production records, such as product batch records, inventory files, and product traceability matrices, as well as other QMS documentation, using sound judgment.
- Manage controlled document distribution and retrieval, coordinate training, manage supplier control and equipment program, maintain quality records, and assist with managing contracts.
- Take the lead in selecting and implementing the eQMS system while maintaining the paper system concurrently until the full transition.
- Contribute to the development of standard operating procedures (SOPs), production-related documents, and documents related to Augurex Product Development activities.
- Collaborate closely with the scientific, commercial and supply chain team to maintain inventory recall capabilities, assist in hosting internal and other QMS audits and plan new product development quality requirements.
- Learn Fishbowl ERP and help manage Augurex R&D inventory.
- Address other assigned tasks, including facilities, landlord, and/or subtenant issues.
- Serve as a Worker Health and Safety Representative, as necessary.
Qualifications And Experience
- Graduate Degree in life sciences (PhD preferred), with 10+ years of experience in Quality Assurance in the biotech industry or an equivalent combination of education and experience.
- Must have excellent computer skills, including proficiency in MS Office Suite, Adobe Acrobat, or equivalent. Familiarity with computer shortcuts and willingness to learn new software is essential.
- Required familiarity with eQMS, ISO 13485, CLSI guidance, and/or other laboratory standards and regulations. Experience in regulated industries like medical device or pharma manufacturing is highly desirable.
- Exceptional attention to detail, coordination skills, and ability to prioritize multiple tasks with minimal supervision.
- Excellent interpersonal, written, and oral communication skills.
- Must have a can-do, positive attitude and be a supportive team player who embraces a culture of growth and change, thriving in a rapidly evolving environment.
Please send your cover letter and resume to hr@augurex.com. Only candidates selected for an interview will be contacted.
ABOUT AUGUREX
Augurex is focused on developing and commercializing biologically-informed near-patient solutions that transform health management for better outcomes. JOINTstat® represents Augurex’s first commercialized blood test that is paving the way for an immunology franchise of pipeline biomarkers with digital health applications for patient-centric care.
The dynamic team of Augurex employees are tenacious, inclusive and have a passion for seeing our products make a difference in people’s lives. From clinical development through to commercialization, we are building an organization based on solid values to transform illness to wellness.
Job type: Full-time, Permanent
Work schedule: 8-hour workday, Monday to Friday
Posting date: 2023-03-24
Benefits:
- Casual dress
- Proximity to SkyTrain and bike routes
- Free parking near by
- Company events
- Dental care
- Disability insurance
- Extended health care
- Flexible schedule
- Life insurance
- On-site gym
- Paid vacation
- Stock options
- Tuition reimbursement
- Vision care
- Wellness program
- Work from home flexibility
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