- Job Type: Full-Time
- Function: Engineering QA
- Industry: Therapeutics
- Post Date: 09/18/2022
- Email: firstname.lastname@example.org
- Website: talaristx.com
- Company Address: 570 S. Preston St, Suite 400, Louisville, KY, 40202
About Talaris TherapeuticsTalaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders.
The Senior Quality Assurance Document Control Specialist is responsible for maintaining and sustaining the records, both electronic and paper, at Talaris. Looking for a hands-on Quality Assurance professional who will assist functional departments to coordinate the creation, routing, approval and archival of GxP documentation in the Talaris EDMS (Veeva) and the Quality Archive paper system.
In addition, the role will also help track, lead, and organize QMS activities, including training, deviation tracking, and other KPIs. This role will ensure that documentation timelines for GMP activities are coordinated in a manner that complies with company timelines and applicable laws, regulations, standards, and guidelines. This role will also be responsible for maintaining, updating, and enforcing the company’s good documentation policies.
Duties and Responsibilities:
- Coordinates and maintains training records, training materials, and metrics utilizing Veeva Vault.
- Provides training as the Subject Matter Expert (SME) on the document control & document training processes
- Leading training administrative tasks in Veeva and assisting staff with training inquires
- Prepares and presents KPI status reports monthly
- Presents QMS and training metrics at Quality Management Reviews
- Leads document control improvement projects
- Coordinates the revision of procedures, specifications, and forms with the functional groups, as needed
- Receives, reviews, controls, and tracks documents per relevant process and procedures
- Identifies any gaps in the document control process and leads process improvements to the document control system
- Assigns and monitors document numbers and part numbers, and updates logs and databases
- Authors and implements procedures related to document control system
- Ensure Talaris document control systems stay compliant with the current FDA and CFR regulations
- Oversees the maintenance of the document management system for Quality Documents
- Maintenance of the physical and electronic systems for legacy quality documents, including filing and scanning
- Leads off-site storage processes and training for staff, including coordinating with the off-site storage company for storage and retrieval of documents
- Performs Good Documentation Practices (GDP) training for staff, both new employees and refresher training
- Perform related duties as assigned
Minimum Education, Training, and Experience Required:
- Bachelor’s degree
- 5+ years of combined quality assurance and document control or equivalent experience required
- Experience with Electronic Document Management Systems; experience with Veeva is preferred
- Proven ability to lead small/medium projects to successful completion
- Knowledge of documentation control requirements for cell therapy/pharmaceutical industries
- Experience performing administrative training program activities
- Working knowledge of cGMP and regulatory requirements
- Solid knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint
- Experience with key cGMP Quality Systems (e.g., Change management, Deviation, CAPA, Training, Documentation)
- Excellent written and verbal communication skills; the ability to effectively write and edit comprehensive documents for a variety of audiences
- Proven ability to work effectively as a team member/lead, including cross-functional teams.
- Proven ability to multitask, to organize and prioritize workload to meet deadlines and corporate objectives in a fast-paced environment
- Highly goal-driven approach and the ability to focus on time-sensitive objectives
- Must be able to work independently with minimal supervision
- Physical condition necessary for walking, standing or sitting for prolonged periods of
- Bending to floor level is required
- Extensive use of computer keyboard
- Lifting up to 20 lbs.
- Competitive compensation including bonus opportunity and equity participation
- Medical / Dental / Vision Insurance
- Company Paid Long & Short Term Disability
- 25 Days Paid Time Off + 10 Paid Company Holiday’s
- 401k with Employer Contribution
- Stock Options and Restricted Stock Units (RSUs)
- Paid Parental and Organ Donor Leave
- Employee Stock Purchase Plan (ESPP)
- Generous Professional Development Policy for Job-Related External Learning Opportunities
- Employee Assistance Program (EAP)
Talaris Therapeutics requires that all employees be fully vaccinated for COVID-19. Proof of vaccination or sincerely held religious belief and/or medical exemption is required upon hire. Talaris Therapeutics will engage in an interactive dialogue process with employees who have documented medical conditions and/or sincerely held religious beliefs that would prevent them from getting vaccinated, in accordance with all applicable laws.
Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ.
We are currently conducting FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, as well as two additional Phase 2 clinical trials: FREEDOM-2, in which we are evaluating the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, and FREEDOM-3 in which we are evaluating the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 120 employees. We maintain corporate offices in Boston, MA in addition to our cell processing facility in Louisville, KY and our process and analytical development labs in Houston, TX.
Equal Employment Opportunity: Talaris Therapeutics is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by emailing us at email@example.com. When emailing, please include a description of your requested accommodation, your name and contact information.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us.