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SalaryYour 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 lead archive activities and implement archive systems to ensure compliance with GLP
requirements. They will perform all necessary lead functions to effectively and efficiently
coordinate personnel assigned. Oversee training of Archive personnel for consistency with procedures. The Lead Archivist will provide feedback to supervisor on employee performance.
What You'll Do Here
- Develop and maintain computerized files to support and maintain archive processes.
- Coordinate the receipt, review, indexing, labeling and archiving of study and facility materials.
- Oversee the checking of materials in and out of the archives.
- Correspond with Sponsors at the end of retention periods and maintain all Sponsor correspondence for easy access.
- Coordinate and document the disposition of study materials according to Sponsor’s request.
- Identify and recommend process improvements for the department.
- Review and update archiving standard operating procedures.
- Participate as company representative on Sponsor and regulatory visits by hosting archive tours and retrieving requested information.
- Coordinate and assign daily activities of the Archive staff.
- Leads process improvement initiatives.
- Help train other employees as needed.
- Acts as the backup for Supervisory duties
- Perform training of staff by conducting training seminars and distributing information on GLP regulatory requirements for archive processes.
- Assist with document review.
- Bachelor’s degree and 2+ years related experience or equivalent combination of education and experience.
- 2+ years of experience in a regulated environment.
- 1 year supervisor experience.
- Demonstrate proficiency in Microsoft Office products.
- Ability to read and interpret documents, writes routine reports and correspondence, and speaks effectively before Sponsors, regulatory agency representatives and groups of employees in the organization.
- Continual GLP training, computer software applications and archive processes.
- Ability to communicate with all levels of management and employees.
- Ability to multi-task and maintain organization in a fast paced, changing environment, administrative experience and records management capabilities.
- Understanding of regulations as they relate to archive responsibilities.
- Proven presentation and facilitation skills.
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
- Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Reviews
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!
