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 Coordinator is to ensure all study and facility data is in accordance with SRC Standard Operating Procedures (SOP's), the study protocol, and Good Laboratory Procedure (GLP) requirements.
What You’ll Do Here
- Maintain competency in the current SRC Standard Operating Procedures (SOPs), GLP regulations, and ALCOA+.
- Reviews protocols and study schedules for all studies prior to data collection. Suggests areas of improvement to the protocol or Pristima schedule, as needed.
- Maintains high data quality standards and performs 100% second party review daily on all study and facility data, including Pristima edits and back-entries. Brings forward suggestions to correct any findings.
- Assists with 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.
- Maintains high standards toward organization and follows through with communications, as well as following up on findings.
- Proposes improvements/refinements in data review capabilities and develops different data review methods to improve efficiency.
- Communicates effectively and professionally with outside departments, management, and other employees. Motivates and mentors team members.
- Work closely with Supervisors, Study Directors, Report Coordinators, and Quality Assurance to resolve data clarity issues.
What You’ll Need To Succeed
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: 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!