Quality Assurance Associate
Columbia, MO, USA
Req #3301
Wednesday, March 15, 2023
Your New Company!
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.
About the Role:
The QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management.
What You'll Do
- Autonomously performs audits of Protocols, Amendments/Amended Protocols, raw data, reports, and supporting documentation for internal accuracy, consistency, and conformance with regulations and SOPs.
- Perform audits of equipment qualifications and computerized systems validations projects for accuracy, consistency and conformance with regulations, SOPs.
- Performs phase inspections of ongoing study/project activities.
- Prepares, issues, and tracks reports of observations noted during audits and inspections.
- Performs facility audits to ensure that the facility is in compliance with regulations.
- Acts as lead auditor on studies and projects.
- Maintains computerized files to support audit activities.
- Supports project planning and implementation.
- Provides risk-based compliance opinions and guidance.
- Identifies compliance gaps in processes, systems and studies; influences and collaborates with employees and management.
- Assists with representing Quality Assurance (QA) in internal work groups.
What You'll Need to Succeed
Bachelor's degree from four-year College or university, or high school diploma with half year related education and/or experience. Affiliation and/or training with a relevant professional organization, such as the Society of Quality Assurance, is highly desirable.
Bachelor's degree from four-year College or university, or high school diploma with half year related education and/or experience. Affiliation and/or training with a relevant professional organization, such as the Society of Quality Assurance, is highly desirable.
What We Offer
Benefits (regular employees)
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
- Telework when applicable
Altasciences' Incentive Programs Include:
- Training & Development Programs
- Employee Referral Bonus Program
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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!Other details
- Pay Type Hourly
- Columbia, MO, USA