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At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences.
The Quality Assurance Auditor coordinates auditing activities to ensure compliance with SOPs and GLP requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews.
What You'll Do Here
- Audits protocols, amendments, raw data, reports and supporting documentation for internal accuracy, consistency, and conformance with regulations and internal SOPs
- Performs phase inspections of ongoing study activities
- Performs facility audits to ensure departmental compliance with the regulations
- Oversees and assists with audits to assure departmental consistency
- Prepares, issues, and tracks reports of observations noted during audits and inspections
- Applies a thorough understanding of compliance to a broad range of regulatory issues
- Maintains computerized files to support audit activities
- Assists in scheduling audits and assigning resources to projects
- Coordinates auditing activities and implements auditing systems to ensure compliance with GLP requirements
- Identifies, evaluates, and implements best practices
- Evaluates interdepartmental processes for improvement opportunities and proposes solutions
- Helps design and develop risk-managed regulatory processes
- Oversees and designs training systems; acts as a lead trainer for new and junior staff
- Drives project planning and implementation; acts as lead auditor on studies
- Solicits and gains support of employees, clients and management through effective collaboration and negotiation; represents QA in workgroups
- Evaluates interdepartmental processes for improvement opportunities and proposes solutions
- Oversees and designs training systems; trains and qualifies trainers on internal processes and procedures
- Communicates with clients regarding regulatory issues
What You'll Need to Succeed
- Bachelor's degree (B. S.) in a scientific discipline, or equivalent combination of education and experience
- Two to three years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment
- Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality - Certified Quality Auditor) or other certification is recommended
- The QA Auditor reports to the QA Supervisor. This individual is responsible for carrying out systematic and independent examination of multiple trial related activities and documents to determine whether the evaluated trail activities were conducted and the data was recorded, analyzed, and accurately reported according to the protocol, SOPs and GxPs and applicable regulator requirements. Report findings to the Internal Study Team and Department Management.
What We Offer
The pay range estimated for this position is $65,000 to $75,000 per year. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' Benefits Package Includes
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
Altasciences' Incentive Programs Include
- Training & Development Programs
- Employee Referral Bonus Program
- #LI-BK1
- Job Family P-4
- Pay Type Salary
