Sr. Quality Specialist - Data Integrity (DI) Program Leader @ Thermo Fisher Scientific - Carlsbad, CA

Job Overview

2 months ago

Sr. Quality Specialist - Data Integrity (DI) Program Leader

Thermo Fisher Scientific - Carlsbad, CA

Sr. Quality Specialist – Data Integrity (DI) Program Leader

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges. This includes protecting the environment, making sure our food is safe, helping find cures for cancer.

Location/Division Specific Information

At the Carlsbad, CA Microbial Manufacturing Services (MMS) site, a business within the Advanced Therapies Division of Thermo Fisher Scientific’s Pharma Services Group, we deliver innovative and life-saving drug products from process development through commercial supply, and we offer expertise and resources to help customers expedite products to market.

How will you make an impact?

The Program Leader, will implement procedures, training and oversight aligned with PSG policies and global regulations to ensure the integrity of data generated to support manufacturing and testing processes. This role owns the DI Plan and will collaborate across functions to ensure targets are met.

What will you do?

As an active member of the site Quality Leadership Team and the Global DI Network:

Implement DI practices and procedures to meet regulatory requirements. Coordinate routine DI Surveillance, weekly DI awareness topics, and monthly reporting to the site leadership team. Collaborate with cross functional teams for continuous improvement of processes to facilitate right first-time documentation. Facilitate risk assessments for new and existing equipment and systems and provide strategic direction for remediation Develop, own, and update procedures as necessary to ensure clear direction and understanding of data integrity principles and requirements. Support the change control and deviation management processes with respect to potential data integrity impact and ensure appropriate implementation actions are carried out to maintain compliance. Serve as the point person during client and regulatory inspections for DI

Education

  • Bachelor’s degree in engineering, chemical / biological science or related technical field.
  • Equivalent combinations of education, training, and relevant work experience may be considered

Experience

  • At least 7 years experience in the pharmaceutical industry with related technical and quality knowledge including laboratory and manufacturing data integrity.

Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment and quality management systems.

Knowledge, Skills, Abilities

  • Strong understanding of current Good Manufacturing Practices and application of 21 CFR Part 11 and Annex 11.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
  • Strong interpersonal and presentation skills with focus on influencing and team building
  • Ability to drive functional, technical and operational excellence.

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has an outstanding story to tell. Join us in our mission to enable 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.

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