Associate Quality Control Coordinator

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 primary responsibility of the Quality Control Associate is to ensure all study and facility data is in accordance with APC Standard Operating Procedures (SOP's), the study protocol, and Good Laboratory Procedure (GLP) requirements.

What You’ll Do Here:

• Maintain competency in the current APC Standard Operating Procedures (SOPs), GLP regulations, and ALCOA+.

• Review draft protocols prior to pre-study meetings and review the final protocol for all studies prior to data collection.

• Prepare for study initiation by attending pre-study meetings.

• Perform 100% second party review daily on all study and facility data, including Pristima edits and back-entries.

• Monitor data corrections suggested by Report Services and Quality Assurance to ensure all corrections to raw data are reflected accurately in the study data.

• Track data recording errors daily during data review and participate in data quality assessments of Operational staff.

• Review final study schedules and daily schedules to ensure conformity of protocol requirements.

• Monitor the study timeline and ensure study data is prepared for Data Hand-off, including resolution of data errors. 

• Maintain study binders and facility record binders to ensure proper filing.

• Work closely with Supervisors, Study Directors, Report Coordinators, and Quality Assurance to resolve data clarity issues.

What You’ll Need to Succeed:

High school diploma or GED and 1 year of relevant experience; Bachelor’s Degree and no previous experience; or an equivalent amount of education and experience.

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!