Manufacturing Compliance Specialist II|
Job Title: Manufacturing Compliance Specialist II
Work Location: Lexington, MA
Division: Pharma Services Group (PSG)
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 specialist in this role will be part of a cohesive team responsible for owning/supporting Deviations and CAPAs for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations, process knowledge, and investigational skills to support manufacturing compliance. The incumbent will support documentation, training, and improvement initiatives within manufacturing operations.
What will you do?
- Lead and own manufacturing investigations, utilizing root cause analysis tools as required to find root cause and contributing factors. Identifies event impact and communicates/presents to Manufacturing and Quality.
- Definition, ownership, and/or support of corrective and preventative actions (CAPA’s) in alignment with Manufacturing requirements.
- Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
- Edit cGMP documents and process through workflow for the creation of quality approved documentation. Cross-functional collaboration with document control and other supporting groups is required.
- Support manufacturing internal and external observations as required.
- Practice and promote safe work habits while adhering to safety procedures and guidelines.
- Support and develop consistent manufacturing/quality standards and/or process for Deviations and CAPAs in Quality Systems
- Conduct complex document revisions and/or document management including batch production records and manufacturing procedures
- Own and maintain tracking systems of manufacturing compliance priorities
- Works cooperatively with others to meet group and organizational goals.
- Participates in initiatives to support innovation and continuous improvement activities
- Improve compliance within quality procedures, policies, and regulations
- Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation
- Bachelor’s in Life Sciences, Engineering preferred
- Minimum of 5 years’ experience in pharmaceuticals manufacturing. Minimum 2 years specialist experience preferred.
- Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
- Strong planning, organization and multitasking skills
- 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, senior associates, and area management within their operational groups
- Solid understanding of applicable regulatory requirements.
Knowledge, Skills, Abilities
- Gown aseptically and/or sterile gown as needed.
- Write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.
- The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
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 mission—enabling 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.