At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary: (12-month duration) Reporting to the Senior Manager of Quality Assurance, the QA Document Control Coordinator is responsible for the review, routing, distribution, labeling and filing of GXP documentation. Update and maintain document tracking databases and archival systems. Assume responsibility for departmental projects and initiatives. Administer Documentation Audit programs for GXP documents. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite, including scanning of documentation. Some physical movement of document files/boxes is required; must be able to lift 30 pounds.

Roles And Responsibilities Of The Position

• Participate in department optimization efforts; take the lead on selected projects and assignments, following them through to closure.
• Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices.
• Issue controlled Production Documentation to Manufacturing and Laboratory Notebooks to cross functional areas; maintain records of issuance.
• Label and code files for storage in on-site Documentation Centers.
• Maintain Change Control, CAPA, Deviations, Lab Investigation, Complaint and Audit systems
• Manage notification to stakeholders and timely completion of Key Performance Indicators (KPI)
• Manage site training program.
• Ensure ethics and compliance commitment at all times. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.
• Participate in department optimization efforts; take the lead on selected projects and assignments, following them through to closure.
• Write and assist others in writing Standard Operating Procedures (SOPs) and manage the approved SOPs.
• Prepare and route documentation packages throughout the review and approval cycle.
• Track document approval activities in manual tracking system; ensuring folders are updated and accurate.
• Assist in Annual GMP Training.
• May perform other related additional duties as assigned

Required Qualifications

• Minimum a College Diploma, preferably focused on sciences.
• Minimum 1-2 years working in the pharmaceutical manufacturing industry
• Knowledge of Records Management practices and principles in a Corporate and GMP environment.
• Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products preferred.
• Experience with MS applications including SharePoint and SmartSheet
• Ability to work typical core business hours, Monday through Friday with shifted schedule to include weekend work on occasion.
• Minimal early or late hours are required on occasion.
• Some physical movement of document files/boxes is required and must be able to lift up to 30 pounds

Additional Preferences

• Demonstrated knowledge in Microsoft Office (including Outlook, Word, Excel, Smartsheet, and PowerPoint).
• Operate and execute with a high sense of urgency.
• Experience with Veeva Vault QMS system

Physical Demands/Travel

• Lifting up to 30lb is required.
• The physical demands of this job are consistent with a lab environment.
• This position’s work environment is in an Office with daily visits to the Laboratory.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Work Environment

• Position is onsite during the work week located Toronto downtown at UHN near College Street and University Avenue.
• This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.

The work environment characteristics describ ed here are representative of those an employee encounters while performing the essential functions of this job.

• To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above 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.

Eli Lilly Canada is committed to employment equity. We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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