The Perfect Addition to Our Team

You are analytical and detail oriented. You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You are detail-oriented and able to review and analyze quality issues quickly in order to provide robust and timely solutions. You are dependable and accountable for your work.You are an excellent team player and relationship builder. 

The Opportunity

The Senior QA Specialist will be responsible for supporting QA processes, including, Vendor Management, Change Control, Training and Management Review. This role is based in Boston, MA and reports directly to the Head of Quality. 

Responsibilities

• Supports Vendor Management Program, including management of vendor audit activities and the Approved Supplier List. 
• Leads planning and execution of Management Review Program.
• Writes and implements changes to Standard Operating Procedures.
• Coordinates and reviews change control activities to drive change control records to closure. 
• Manage Quality foundational processes and supports GxP owners with implementation and improvement.
• Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records.
• Performs the appropriate QA review/approval of SOPs, SOP-related documents, and Policies.
• Partners with functional groups and vendors to ensure alignment of records archival.
• Leads and supports understanding and adoption of risk-based approaches and decision making.
• Serve as Quality resource, representing QA on teams in support of assignments.
• Supports all GxP functions as needed. 

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• Minimum BS degree; Science or Engineering discipline preferred.
• 5 years of experience in a GxP environment.
• Previous experience working with quality systems having oversight of GxP operations including some or all of the following: Document Control, Training, Change Control, Management Review, Batch Documentation.
• Demonstrated experience in regulatory inspection activities.
• Ability to work on multiple projects on a tight timeline.
• Ability to prioritize and the flexibility to adapt to changing priorities.
• Experience working successfully both independently and in a team environment.
• Strong verbal and written communication skills.