DESCRIPTION
Augurex Life Sciences Corp, hiring within the Biotech / Medtech industry, has an immediate opening for a QARA/Records Control Coordinator. 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, Augurex is the place for 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.
As a member of the Quality Assurance and Regulatory Affairs (QARA) team, the QARA/ RC Coordinator is responsible for production batch reviews, processing document change requests, coordinating the Augurex training, equipment, and supplier control programs, and handling general administrative responsibilities. The ideal individual will have high attention to detail and ability to plan and prioritize during high and low-volume work times. The successful candidate thrives in a fast paced, high-performing collaborative environment, and has exceptional oral and written communication skills.
ROLE AND RESPONSIBILITIES
- Perform production batch review and data QA review.
- Process Change Requests to completion and manage controlled document distribution and retrieval.
- Coordinate training, maintain employee training files as well as implement and train personnel on document and records control procedures.
- Maintain supplier and equipment records and provide support with managing contracts.
- Assist in drafting standard operating procedures (SOPs), production related documents and documents related to Augurex Product Development activities.
- Maintain the inventory recall capabilities in collaboration with Supply Chain Management and assist with internal and other Quality Management System (QMS) audits.
- File all Augurex QMS records and ensure they are maintained as per written procedures.
- Act as the principal operator/ QA administrator for the future eQMS (electronic QMS) implementation and maintenance.
QUALIFICATIONS AND EXPERIENCE
- Diploma or B.Sc. Degree in life sciences or related field, 3+ years of experience in records management, document control or quality assurance and/or an equivalent combination of education and experience.
- Familiarity with ISO 13485 and/or ISO 15189 standards, CLSI guidance and other standards and regulatory documents is required, experience in medical device manufacturing is an asset.
- Outstanding interpersonal, oral, and written communication skills and computer proficiency (MS Office Suite); experience with eQMS implementation and maintenance is a strong asset.
- Exceptional coordination skills and unparalleled attention to detail and ability to perform and prioritize multiple tasks seamlessly and with minimal supervision.
- Superior problem-solving skills, oral and written communication, and familiarity with creating SOPs.
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 Types: Full-time, Permanent
Benefits:
- Casual dress
- Commuter benefits
- Company events
- Dental care
- Disability insurance
- Discounted or free food
- Extended health care
- Flexible schedule
- Life insurance
- On-site gym
- On-site parking
- Paid time off
- Stock options
- Tuition reimbursement
- Vision care
- Wellness program
Schedule:
- 8-hour shift
- Monday to Friday
COVID-19 considerations: Face masks are required in hallways and when away from the desk.
Comments are closed.