As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

The position provides management of all resources for raw material sampling and inspection at PCS facilities. Additionally, ensures overall program and product quality improvement by leading the team in continuous process improvements by implementing preventative actions and reviewing lessons learned.

What will you do?

• Ensure the cleanrooms are maintained and certified to meet industry standards and the requirements of customers
• Provide commercial support and be a customer facing expert by working closely with customers on implementation of quality related services and capabilities through customer meetings, presentations and timely follow-up.
• Develop the required processes and systems and write and follow standard operating procedures related to the raw material sampling function and other cGMP quality related services and capabilities as needed to support customer requirements and expectations.
• Designs quality assurance programs and processes for quality inspection, to ensure product quality and compliance with customer requirements.
• Leads teams within PCS and BPG to create and/or modify processes and procedures to ensure that appropriate processes are developed to meet required customer and regulatory standards.
• May perform statistical analysis to analyze trends, and works to investigate, conduct root cause analysis, and recommend corrective actions for processes and products. Tracks data to support site level metrics (e.g. CAPA, complaints and on time sampling)
• Leads teams to conduct root cause analysis as applicable to sampling and inspection processes
• Works directly with customers on critical sampling and inspection processes. May lead issue/complaint resolution when root cause is traced to sampling or inspection processes
• Seen as subject matter authority supporting sampling and inspection.

How will you get here?

Education:

• Minimum required education: Bachelor’s degree in Chemistry, Biology, Biochemistry or Environmental Sciences

Experience:

• 5 years of proven experience in quality assurance / quality control
• 2 years of direct supervisory experience
• Experience with Compliance & quality standards (e.g., 9001, 21 CFR, GxP)
• Broad/well-rounded process knowledge
• Multi-site/Global software programs experience
• Quality tools e.g. FMEA, Risk Analysis, RCA, Analysis, etc.
• Site specific software programs (Intelex Document Control, Training, PM &Calibration, SalesForce, Aplus, etc.).

Knowledge, Skills, Abilities:

• Candidate will work independently, as well as, on teams within the site (Procurement, Sales, Production Ready Services and Operations).
• Must have the ability to multitask in a fast-paced environment and prioritize work.
• Completes tasks of moderate scope where analysis of situations or data requires problem-solving skills.
• Excellent written and oral communication skills are required.
• Accuracy and attention to detail is required in performing all functions of this position. Initiative, interpersonal and computer skills are extremely valuable to ensure effective sampling operations.
• Candidate must be customer centric; Must demonstrate judgment, tact, and diplomacy in taking care of internal and external customers.
• Works in a team-oriented environment in order to support all daily functions of the sampling sites.
• Must possess self-motivation and the ability to work on routine analysis with no instructions or new assignments with limited instructions.
• Must be able to work safely with chemicals, biologics and hazardous materials.
• Global Systems e.g. TrackWise
• Must be able to travel up to 20% of the time.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

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