Thermo Fisher Scientific QA Project Manager - Quality and Systems in Saint Louis, Missouri
When your part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
St. Louis, MO - Pharma Services Division - Biologics
How will you make an impact?
The QA Project Manager will perform specialized level work assignments regarding Quality Systems, general Quality projects, and change control.
What will you do?
Work with the global network for applicable Quality Systems - including identifying and facilitating site requirements for improvements to systems, monitoring health of systems through appropriate metrics, adjusting metrics as needed, and collaborating with departments regarding action items to negative metrics.
Utilize project management principles to drive accountability of deviations, CAPAs, Change Controls and work with departments to identify solutions.
Support site subject matter experts, assessors, and approvers for the Change Control system.
Works closely with site change owners on strategy of change implementation and supporting the facilitation of completion when delays occur.
May serve as an administrator for change control module, providing overall quality oversight to ensure accuracy and completeness of changes implemented.
Work collaboratively with Business Analyst(s) to support and drive implementation of new electronic Quality Systems at the site.
Identify resources for the development of policies and procedures supporting Quality Systems and Quality Assurance.
Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Communicate information to external customers, as needed.
Perform other related duties and responsibilities, on occasion, as assigned.
How will you get here?
Bachelor's degree in Life Sciences, Biotechnology, or equivalent
Minimum of five years' experience in a cGMP manufacturing environment
Minimum of three years' experience in a cGMP manufacturing environment in a Quality role.
Minimum of two years' experience in a project management role
Experience in sample management, documentation, deviation, and process monitoring systems a plus.
Knowledge, Skills, Abilities
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Excellent communication skills and attention to detail.
Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude.
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
Proficient in MS applications (Excel, Word, Outlook).
Must be able to write clear, understandable technical documentation\. Excellent oral presentation skills.
Ability to follow written and verbal directions with a high level of accuracy.
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.