Job Search Assistant
Manager, Quality
ThermoFisher Scientific • Durham, NC 27722 • Posted 5 days ago
Boost your interview chances in seconds
Tailored resume, cover letter, and cheat sheet
In-person • Full-time • Mid Level Manager
Job Highlights
Using AI ⚡ to summarize the original job post
The Manager, Quality at ThermoFisher Scientific is responsible for managing all resources for raw material sampling and inspection, including management of complaints and validation activities. This role involves ensuring cleanrooms meet industry standards, providing commercial support, developing processes and systems, leading teams in continuous process improvements, and owning the complaint processes. The position requires a Bachelor's degree in a relevant field or equivalent experience, with a minimum of 6 years of experience in quality assurance/quality control and direct supervisory responsibilities.
Responsibilities
- Ensure the cleanrooms are maintained and certified to meet industry standards and customer requirements.
- Provide commercial support and be a customer-facing authority for quality-related services.
- Develop processes and systems related to raw material sampling, validation, and complaint functions.
- Lead teams to build and/or modify processes and procedures to meet regulatory standards.
- Manage the validation master plan and ensure appropriate validation is conducted.
- Own the complaint processes and drive issue resolution.
- Perform statistical analysis and recommend corrective actions for processes and products.
- Work directly with customers on critical sampling and inspection processes.
- Ensure overall program and product quality improvement through continuous process improvement.
Qualifications
Required
- Bachelor's degree in Chemistry, Biology, Biochemistry, Environmental Sciences, or equivalent experience.
- Minimum of 6 years of experience in quality assurance/quality control with direct supervisory responsibilities.
- Experience with Compliance & Quality standards (e.g., 9001, 21 CFR, GxP).
- Broad/well-rounded process knowledge including validation.
- Multi-site/Global software programs experience.
- Knowledge of quality tools (e.g., FMEA, Risk Analysis, RCA, Analysis).
Preferred
- Excellent written and oral communication skills.
- Multitasking ability in a fast-paced environment.
- Flexibility in prioritizing work.
- Initiative, interpersonal and digital literacy.
- Customer centric with judgment, tact, and subtlety in dealing with internal and external customers.
- Ability to work in a team-oriented environment.
- Self-motivation and ability to work on routine analysis with no instructions or new assignments with limited instructions.
- Ability to work safely with chemicals, biologics, and hazardous materials.
- Knowledge of Global Systems (e.g., TrackWise).
About ThermoFisher Scientific
Thermo Fisher Scientific is a multinational biotechnology company that provides a wide range of products and services in the scientific research and diagnostics industry. They offer scientific instruments, laboratory equipment, diagnostic testing solutions, and more to customers worldwide in industries such as pharmaceuticals, biotechnology, healthcare, academia, and environmental research. Thermo Fisher Scientific is known for its high-quality products, robust R&D capabilities, and strategic acquisitions that have solidified its position as a leader in the market.
Full Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
At Thermo Fisher Scientific team, 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, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
**Company Information**
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. It also has management responsibility of complaints and validation activities at PCS. 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 authority 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, validation, and complaint functions and other cGMP quality related services and capabilities as needed to support customer requirements and expectations.
+ Leads teams within PCS and BPG to build and/or modify processes and procedures to ensure that appropriate processes are developed to meet required customer and regulatory standards.
+ Management of the validation master plan, as well as, assuring that processes and procedures ensure appropriate validation is being conducted throughout the organization including warehouse temperature mapping, computer system validations(CSV), and cleanroom validations.
+ Ownership of the complaint processes within the organization. Drives appropriate action and brings supplier complaints to closure.
+ 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)
+ Works directly with customers on critical sampling and inspection processes. May lead issue/complaint resolution when root cause is traced to sampling and inspection processes
+ Seen as subject matter authority supporting sampling and inspection, validation, and complaint management.
+ Ensures overall program and product quality improvement by leading cross-functional teams in continuous process improvement implementing preventative actions and reviewing lessons learned.
**Education:**
+ Minimum required education: Bachelor's degree in Chemistry, Biology, Biochemistry, or Environmental Sciences. Equivalent experience in the field will also be considered.
**Experience:**
+ Minimum of 6 years of experience in quality assurance / quality control with direct supervisory responsibilities.
+ Experience with Compliance & Quality standards (e.g., 9001, 21 CFR, GxP)
+ Broad/well-rounded process knowledge including validation
+ Multi-site/Global software programs experience
+ Quality tools e.g. FMEA, Risk Analysis, RCA, Analysis, etc.
**Knowledge, Skills, Abilities:**
+ Candidate will work independently, as well as, on teams within the site (Procurement, Sales, Production Ready Services and Operations).
+ Multitasking ability in a fast-paced environment and flexibility in prioritizing work.
+ 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 digital literacy are very valuable.
+ Candidate must be customer centric; Must demonstrate judgment, tact, and subtlety in dealing with internal and external customers.
+ Works in a team-oriented environment in order to support all daily functions of the global sites.
+ Must possess self-motivation and the ability to work on routine analysis with no instructions or new assignments with limited instructions.
+ Work safely with chemicals, biologics and hazardous materials.
+ Global Systems e.g. TrackWise
+ Travel up to 20% of the time.
Our Mission is to help our customers create a healthier, cleaner, and safer world. Take a look at our colleagues' video where they discuss why it's great to work with us. At Thermo Fisher Scientific, we have a team of 100,000 colleagues working together to solve scientific challenges, accelerate research, drive innovation, and support patients in need. Join us and #StartYourStory, where we value diverse experiences, backgrounds, and perspectives.
**Benefits of Joining Thermo Fisher Scientific Inc.:**
+ Opportunity to work for a globally recognized leader in serving science
+ Access to world-class training and development programs to enhance your skills and knowledge
+ Collaborative and inclusive work environment that values diversity and promotes employee growth
+ Competitive compensation package with comprehensive benefits, including medical, dental, and vision coverage
+ Generous paid time off and flexible work arrangements to promote work-life balance
**Advancement opportunities within a growing organization that values internal talentApply 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.
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.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
At Thermo Fisher Scientific team, 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, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
**Company Information**
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. It also has management responsibility of complaints and validation activities at PCS. 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 authority 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, validation, and complaint functions and other cGMP quality related services and capabilities as needed to support customer requirements and expectations.
+ Leads teams within PCS and BPG to build and/or modify processes and procedures to ensure that appropriate processes are developed to meet required customer and regulatory standards.
+ Management of the validation master plan, as well as, assuring that processes and procedures ensure appropriate validation is being conducted throughout the organization including warehouse temperature mapping, computer system validations(CSV), and cleanroom validations.
+ Ownership of the complaint processes within the organization. Drives appropriate action and brings supplier complaints to closure.
+ 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)
+ Works directly with customers on critical sampling and inspection processes. May lead issue/complaint resolution when root cause is traced to sampling and inspection processes
+ Seen as subject matter authority supporting sampling and inspection, validation, and complaint management.
+ Ensures overall program and product quality improvement by leading cross-functional teams in continuous process improvement implementing preventative actions and reviewing lessons learned.
**Education:**
+ Minimum required education: Bachelor's degree in Chemistry, Biology, Biochemistry, or Environmental Sciences. Equivalent experience in the field will also be considered.
**Experience:**
+ Minimum of 6 years of experience in quality assurance / quality control with direct supervisory responsibilities.
+ Experience with Compliance & Quality standards (e.g., 9001, 21 CFR, GxP)
+ Broad/well-rounded process knowledge including validation
+ Multi-site/Global software programs experience
+ Quality tools e.g. FMEA, Risk Analysis, RCA, Analysis, etc.
**Knowledge, Skills, Abilities:**
+ Candidate will work independently, as well as, on teams within the site (Procurement, Sales, Production Ready Services and Operations).
+ Multitasking ability in a fast-paced environment and flexibility in prioritizing work.
+ 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 digital literacy are very valuable.
+ Candidate must be customer centric; Must demonstrate judgment, tact, and subtlety in dealing with internal and external customers.
+ Works in a team-oriented environment in order to support all daily functions of the global sites.
+ Must possess self-motivation and the ability to work on routine analysis with no instructions or new assignments with limited instructions.
+ Work safely with chemicals, biologics and hazardous materials.
+ Global Systems e.g. TrackWise
+ Travel up to 20% of the time.
Our Mission is to help our customers create a healthier, cleaner, and safer world. Take a look at our colleagues' video where they discuss why it's great to work with us. At Thermo Fisher Scientific, we have a team of 100,000 colleagues working together to solve scientific challenges, accelerate research, drive innovation, and support patients in need. Join us and #StartYourStory, where we value diverse experiences, backgrounds, and perspectives.
**Benefits of Joining Thermo Fisher Scientific Inc.:**
+ Opportunity to work for a globally recognized leader in serving science
+ Access to world-class training and development programs to enhance your skills and knowledge
+ Collaborative and inclusive work environment that values diversity and promotes employee growth
+ Competitive compensation package with comprehensive benefits, including medical, dental, and vision coverage
+ Generous paid time off and flexible work arrangements to promote work-life balance
**Advancement opportunities within a growing organization that values internal talentApply 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.
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.
Search for other jobs like this one:
Search for popular related roles:
Manager, Supplier Quality jobs in Durham, NCQuality Manager jobs in Durham, NCQuality Services Manager jobs in Durham, NCManager, Quality Standards and Control jobs in Durham, NCManager, Show Quality jobs in Durham, NCTechnical & Quality Manager jobs in Durham, NCManager Quality Assurance jobs in Durham, NCManager, Quality jobs in Durham, NCManager Trainee - Quality jobs in Durham, NCManager - Quality Control jobs in Durham, NC
Search nearby locations hiring for this role:
Manager, Quality jobs in Oxford, NCManager, Quality jobs in Raleigh, NCManager, Quality jobs in Hillsborough, NCManager, Quality jobs in Elon, NCManager, Quality jobs in Holly Springs, NCManager, Quality jobs in Wake Forest, NCManager, Quality jobs in Garner, NCManager, Quality jobs in Graham, NCManager, Quality jobs in Henderson, NCManager, Quality jobs in Apex, NC