Manufacturing Documentation Specialist 

Meet The Team

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The Manufacturing Documentation Specialist II reports into the Viral Vector Services group at Thermo Fisher Scientific and is based in the Cambridge, MA office. The Specialist II in this role will be part of a cohesive team responsible for the lifecycle of manufacturing documentation: record issuance, ensuring reviews are completed in real time on the manufacturing floor, initiating investigations, assisting with the issuing of materials, assisting with documentation corrections, and ensuring documents are submitted to the quality organization in a timely manner. The Specialist II may need to assist with deviations, CAPAs, and Change Controls for all phases of manufacturing. The Specialist II uses expert knowledge of cGMP regulations and project management to ensure manufacturing document readiness. The incumbent will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and exercises independent judgment and discretion.

This position is Monday through Friday, 1st shift.

What will you do?

• Review manufacturing Processing Batch Records (PBR) on the manufacturing floor in real time.
• Ensure timely submission of PBRs.
• Issue materials through Batch Lot Verification (BLV) in SAP.
• Initiate and own deviation investigations.
• Assist with record issuance.
• Interface with and assist the RSO group with documentation improvement.
• Support manufacturing with documentation associated corrective and preventative actions.
• Support manufacturing internal and external observations.
• Support daily tier huddle meetings as needed.
• Practices and promotes safe work habits and adheres to safety procedures and guidelines.
• Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.

Maintain and Improve Systems:

• Performs training with staff for documentation reviews, good documentation practices, deviations, change controls, and CAPAs as needed.
• Supports cross-functional continuous improvement teams, with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology.
• Supports cross-functional company goals for site metrics.
• Builds cross-functional relationships and enhances relationships with team members.
• Works cooperatively with others to meet group and organizational goals.
• Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.
• Participate in client and planning meetings as requested.

Education/ Experience

• Bachelor’s Degree in a scientific field highly desired.
• Minimum of 5 years’ experience in pharmaceuticals manufacturing and/or quality.
• Demonstrated ability to motivate exempt and non-exempt employees and demonstrated project management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
• Thorough knowledge of cGMPs.
• Strong interpersonal and communications skills: written and oral.

Knowledge, Skills, Abilities

• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to make decisions and work with minimal to moderate supervision.
• Able to provide effective written or verbal communication to peers, staff, and area management within their operational groups.
• Strong planning, organization, and multitasking skills.
• Solid understanding of root cause analysis tools.
• Strong Leadership skills.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.