Process Quality Lead|
When you are 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.
How will you make an impact?
This position reports to the Head of Quality for MMS and is responsible for being the Quality interface with customers contracting manufacturing and testing of plasmids with Thermo Fisher Scientific. The role includes being the point of contact for all quality matters regarding the customer product both with internal and external groups. This may include QA assessment of product specific change controls, deviations, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker and customer representative. In addition, this role will manage and facilitate customer quality requests and quality actions by working closely with multifaceted teams such as Manufacturing, MSAT, QC, Engineering and Facilities.
What will you do?
- Represent Thermo Fisher Scientific with customer for all quality items
- Convey to Thermo Fisher Scientific customer concerns and expectations
- Provide quality oversight of customer requests
- Organize and prioritize QA tasks, meetings and agenda items
- QA reviewer and approver on product quality system events
- Interface with multiple departments on customer quality matters
- Drive timely decisions and facilitates active communication and information between department management
- Demonstrate substantial knowledge of industry best practices and trends
- Other tasks as assigned by Site Head or Product Quality Head
- Work effectively with people, including good investigation, problem solving and organization skills
How will you get here?Responsibilities:
BS/MS in Biology or related science discipline and experience in a cGMP manufacturing or QA Operations environment, with strong knowledge of GMP operations and regulations. Experience in cell or gene therapy, project management, QA operations and lot disposition.
- Proficient in cGMPs applicability and decision making
- Experience in quality operations and quality systems
- Skilled in project management tools, and multitasking
- Demonstrated ability in decision making and providing direction to operators on next steps
- Excellent written and verbal communication skills
- Capable to interface with multiple departments and work in cross functional teams
- Must have attention to detail and good investigation, problem solving and organizational skills
- Ability to work effectively with people and communicate challenging information and obtain positive results
- Works well and facilitates positive interdepartmental interactions with a diverse group of people. Voluntarily communicates needs and suggestions clearly and effectively. Listens and is attentive to others
- Capable of being flexible as required tasks change and maintain productivity
- Keeps project leads and team members informed of the status of assigned work
- Must be a strong, dependable team player
- Ability to work with Microsoft Office applications
- Resolve differing perspectives with effective negotiation skills
- Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects/tasks to completion
Knowledge, Skills, Abilities
- Skilled in use of Microsoft Outlook, Powerpoint, Word, TrackWise, LIMS, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
- This position requires the ability to work in a fast-paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
- Able to review and provide details to ensure accurate written records, manage time effectively and be organized
- Ability to communicate effectively to internal and external customers, management and department leads.
- Ability to manage multiple projects at one time