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. Lab auditing preferred
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
What We Offer
The pay range estimated for this position is $67,500 to $85,000 per year. Please note that 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. May consider Senior level Auditors as well.
Benefits
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
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
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Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Research Services
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