Job Description

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.

Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need. We work in close collaboration with each client's team to deliver successful programs. Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases. The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients. This exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market.

Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we'll enable breakthroughs in science that improve patients' lives and bring hope for a healthier world!

How will you make an impact?

The QC Compliance and Training Specialist will work with a team of Scientists and analysts to support deviation investigations as well as coordinating and in some cases providing the training of new personnel within the analytical GMP QC laboratory. The QC-CAT Specialist will work cohesively with QC Management to ensure consistent delivery and execution of high-quality investigations as well as establishing and implementing a training plan that will allow for improved redundancy.

What will you do?

* Independently and in consultation with other QC scientists lead and facilitate investigations (OOS/OOT, etc) and deviations that occur within the QC laboratory.
* Support developing and documenting CAPAs and Change Controls necessary for addressing deficiencies and improving processes.
* Establish and implement a training plan for new hires to ensure redundancy in current assays being performed in the laboratory. Coordinate the training of the new hires with existing Qualified Trainers.
* Establish and implement a training plan for all QC employees to ensure redundancy in current assays being performed in the laboratory or newly established methods as well as ancillary training required for maintaining lab compliance. Coordinate the training of employees with existing Qualified Trainers.
* Become a Qualified Trainer on compendial assays and more complex assays as well.
* Create and revise documents to ensure compliance with the requirements of various regulatory agencies.
* Create training tools which could include videos and powerpoints.
* Other duties as assigned by supervisor.

This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.

How will you get here?

Education

* A Bachelors degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization.

Experience

* Five years of appropriate experience. College coursework may substitute at an equivalent rate for the required experience.
* Laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are required for this position. QA or QC experience in analytical testing and development is strongly recommended.
* Previous experience with Laboratory Information Management Systems and other Electronic Document Systems (eg. Trackwise, EtQ, etc)

Knowledge, Skills, Abilities

* Electronic organizational skills using Microsoft office programs such as Word, Excel, and PowerPoint.
* Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to speak effectively before groups of customers or employees of organization.
* Ability to communicate/work in a high pressure/high paced environment
* Ability to multi-task and function effectively as a member of a team

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.