Summary of job description:This position provides cross-functional support of GXP activities as they relate to Quality
Systems. This position will participate in the improvement of Quality Systems to ensure
quality and adherence with current Good Manufacturing Practice (cGMP) and inspection
readiness.
Key responsibilities:- Archive, organize, and maintain controlled documents and records in compliance with quality and regulatory requirements.
- Coordinate the shipment, tracking, storage, and retrieval of documents sent to off-site archival facilities.
- Prepare, verify, and package-controlled documents for off-site archival storage, ensuring accuracy, completeness, and compliance with document retention procedures.
- Create, issue, and maintain logbooks, laboratory notebooks, and batch records to support operational and quality system activities.
- Manage and prioritize document-related requests through the Jira ticketing system, ensuring timely resolution and customer support.
- Process, route, review, and maintain controlled documents within the MasterControl electronic document management system. Includes formatting documents, creating training courses, etc.
- Ensure document accuracy, version control, and compliance with established procedures and Good Documentation Practices (GDP).
- Support document lifecycle activities, including creation, revision, approval, distribution, archival, and retirement of quality system documents.
- Collaborate with cross-functional departments to facilitate document control processes and maintain audit-ready records
- Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
- Administer and support the MasterControl document management system, managing user access, document workflows, troubleshooting, and compliance with quality system requirements.
- Assist with employee "on-boarding" training on general quality specific procedure requirements.
- Participate in the internal audit program.
- Create and modify user groups, training items, curricula, group trainings and assignments.
- Assist with preparation of OMS metrics.
- Support continuous improvement projects to enhance quality system performance and operational efficiency.
- Support Quality Records, VEEVA system. Create reports, dashboards, ability to pull metrics and assist in admin type activities.
JOB REQUIREMENTS:- Highly motivated individual with excellent time management skills.
- Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
- Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
- Excellent written and oral communication skills.
- Ethical, self-motivated and self-directed.
- Ability to lift boxes ~15Ibs
Preferred Qualifications:- Experience with electronic document and quality management systems, including MasterControl and Veeva.
Educational requirements:- Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience
- A minimum of 4 years of relevant experience required.
Salary RangeReplimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $101,500 -$131,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
