Quality Systems Specialist

Quality Systems Specialist is responsible for the maintenance, delivery, and continuous improvement of Adicet’s Quality Management System (QMS). The role’s main responsibility is to support the Document/Records/Training Management systems.

The position requires strong attention to details, ability to work independently and cross-functionally to perform quality systems activities against Adicet’s policies, procedures, and applicable regulatory regulation. 

Key responsibilities:

• Maintenance, delivery and continuous improvement of Adicet’s hybrid (electronic and paper-based) QMS.
• Work cross-functionally to ensure alignment, implementation, and compliance of quality systems.
• Provides end-user support, guidance, and training on Document/Records/Training Management processes.
• Support implementation, administration, and maintenance of eQMS.
• Support the life-cycle of documents (creation, distribution, revision, review cycle, retirement) in the eQMS.
  • Review and approve change requests for document workflows.
  • Review and process documents to ensure adherence to document management procedural requirements (e.g. formatting, templates) and document life-cycle.
  • Issuance and reconciliation of controlled documents (e.g. batch records, logbooks, protocols).
  • Manage periodic review process to ensure controlled documents are up to date with internal and regulatory requirements.
• Responsible for the records management process to ensure GxP documents are appropriately retained, retrievable, and destroyed per appropriate policies, procedures, and regulatory requirements.
• Assist with administration, maintenance, and effectiveness of Training Program, including training curriculum assessments and updates.
• Develop, generate, and report out of GxP QMS Key Performance Indicators (KPI).
• Support and participate in audits and inspections.

Qualifications:

• BS preferred or related experience in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science.
• Two to four years of experience in Quality Assurance/Systems, or related role within the biotech/pharmaceutical and/or cell/gene therapy industries.
• Experience working with electronic Document Management Systems such as Veeva, TrackWise, MasterControl, ComplianceWire or others similar is preferred.
• Strong skills with Microsoft Suite such as Microsoft Word, Excel and PowerPoint.
• Knowledge of GxP, ICH, EU and CFR requirements and regulations.
• Ability to work cross-functionally with colleagues of various levels of experience and management.
• Excellent written/oral communication skills.

Benefits

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.