When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.
Location/Division Specific Information
We have industry leading sterile injectable facilities providing solutions to take crucial product from Pre-Clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointments and injectables
How will you make an impact?
Provide Quality oversight in the steriles lab for processes and projects, performs compliance assessments, makes decisions regarding regulatory requirements, writes new procedures and ensures adherence to current regulations.
What will you do?
- Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.
- Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity. Performs quality review and approval of deviation and change control of moderate to high complexity.
- Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
- Acts as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
- Performs QA batch disposition (release decisions).
- Works on issues of moderate to sometimes high complexity regarding compliance of processes and product within facilities, equipment, manufacturing and support areas.
- Makes decisions while taking into account level of risks in regard to compliance and product quality.
- Partner with customers on findings and analysis.
How will you get here?
Education
- Bachelor degree required, preferably in technology, engineering, scientific related field or related field
Experience
- A minimum of 5 years of experience with previous experience in Quality Assurance, Quality Control environment Analytical Lab Experience preferred.
- Equivalent combinations of training and relevant work experience may be considered if at least a bachelor degree is acquired.
- Previous experience in a cGMP environment.
Knowledge, Skills, Abilities
- Able to maintain focus and prioritize in a fast paced and evolving environment.
- Comfortable building rapport with internal and customer customers.
- Confirmed problem solver and effective decision maker.
At Thermo Fisher Scientific, each one of our 80,000 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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.