Quality Specialist III

1 month ago


Cranbury, New Jersey, United States Thermo Fisher Scientific Full time

Job Description

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.

Location/Division Specific Information

Our Recombinant Proteins (REP) Business Unit in Cranbury, NJ is part of our Biosciences Division. REP unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies and ELISA kits used to support the research of our academic, government, biotech, and pharmaceutical customers.

Discover Impactful Work:

The Quality Assurance and Support Analyst performs various duties relating to maintaining the quality and consistency of products sold to customers as well as preparing and maintaining necessary documentation. This employee is responsible for initiating tests, reporting results, updating records, responding to inquiries, and other tasks pertaining to the company's products. The employee performs all duties in accordance with leading standards, practices, and guidelines. The role will report to the Quality Assurance Manager- Recombinant Proteins Business.

A Day in the Life:
  • Provide quality assurance and quality control proficiency testing concepts, operating principles, regulations, and methodologies to evaluate and resolve complex laboratory issues.
  • Maintain working knowledge of inspection, testing, and measurement techniques, including statistical analysis and sampling techniques, to study quality problems in a laboratory environment.
  • Coordinate in-house and external QC testing activities and material disposition (authorize batch releases, holds and discards).
  • Analyze and report all QC tests (Biological assays, HPLC, SDS-PAGE gels, Endotoxin, ELISA, etc.).
  • Interface with clients to handle all product inquires and complaints - through phone calls, emails, website, etc.
  • Perform and direct root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
  • Review scientific publications to identify product usage and update our website accordingly.
  • Complete change notifications, advising not only office worldwide, but also distributors.
  • Coordinate updates for the company website with relevant product updates and responses.
  • Coordinate support inquiries and provide updates to offices worldwide.
  • Generate all certificates and SDS for products.
  • Support and maintain the Quality System.
  • Provide product support and updates to offices worldwide.
  • Follow ISO 9001 and GMP guidelines, where applicable.
  • Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four I's).
Keys to Success: Education
  • Bachelor's degree is required.
Experience
  • Minimum of 1-2 years' work experience in a similar or relevant field.
Knowledge Skills and Abilities
  • Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
  • Strong ability to work independently and as part of a team.
  • Capability of working without direct supervision.
  • Excellent interpersonal skills.
  • Strong attention to detail with the ability to detect errors and inconsistencies in various types of documents.
  • Ability to create, revise and interpret complex technical documents.
  • Strong computer skills: application proficiency and database management with Word, Excel, Adobe Acrobat, and other programs as required.
  • Flexibility and willingness to work in a team-based environment.
  • Ability to prioritize among multiple projects while maintaining deadlines.
  • Ability to analyze and define problems, collect data, establish facts, and draw valid conclusions.
  • Knowledge of ISO 9001 standard and certification requirements preferred, or training will be provided as needed.

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 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

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 *. 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.


  • Buyer/planner Iii

    2 weeks ago


    Cranbury, New Jersey, United States Thermo Fisher Scientific Full time

    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...


  • Cranbury, United States Thermo Fisher Scientific Full time

    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...


  • Cranbury, United States Hunter Hamilton Full time

    Accounts Receivable Analyst III Location: Cranbury, NJ Position Type: Temp to Hire Reference ID: 1779186 Salary: $30.00 - $33.00 Date Posted: 2024-05-15 Description: We are seeking an Accounts Receivable Analyst III for one of our best clients in the Cranbury NJ area. Our client is a global leader in the beauty industry by offering every person...


  • Cranbury, United States Joulé Full time

    Title: Document Specialist Location: Cranbury, NJ Schedule: M-F Full Time Type: Direct Hire Responsibilities The Document Specialist is responsible for maintaining all production and quality related documents according to the SQF & FDA requirements. The Document Specialist s


  • Cranbury, United States Empower Pharmacy Full time

    Company Overview Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets. What sets us apart is...

  • Procurement Specialist

    2 months ago


    Cranbury, United States Porton Pharma Solutions Ltd. Full time

    Job description Job Description Procurement Specialist Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we...


  • Cranbury, United States Porton Pharma Solutions Ltd. Full time

    Job description Job Description Procurement Specialist Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we...


  • Cranbury, United States Porton Pharma Solutions Ltd. Full time

    Job description Job Description – Procurement Specialist Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction,...


  • Cranbury, United States Porton Pharma Solutions Ltd. Full time

    Job descriptionJob Description – Procurement SpecialistPorton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we...

  • Procurement Specialist

    2 months ago


    Cranbury, United States Porton Pharma Solutions Ltd. Full time

    Job descriptionJob Description – Procurement SpecialistPorton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we...


  • Cranbury, United States Innvoke, LLC Full time

    Job DescriptionJob Description*Please only read this if you are looking to join a progressive, fast-paced team and want to learn, teach, and share your expertise in bindery, cutting, folding, perfecting, and adding the finishing touch on high-quality print work for high-end clients.*Innvoke, LLC is a fully automated print company with a team of dedicated...


  • Cranbury, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: ssist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective. Process engineering and project management to support remediation projects. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed...


  • Cranbury, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: ssist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective. Process engineering and project management to support remediation projects. These projects are typically of increased complexity and can pose significant risk to product and processes if not...


  • Cranbury, United States Thermo Fisher Scientific Full time

    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...

  • Buyer/planner Iii

    2 weeks ago


    Cranbury, United States Thermo Fisher Scientific Full time

    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...

  • Receiving Specialist

    1 month ago


    Cranbury, United States A&M Industrial Full time

    A&M Industrial is a 70-year-old, family-owned leading local industrial distribution company looking for career-oriented individuals to fill critical positions their warehouse logistics staff. The growth of the company has created full time opportunities in their distribution center in Cranbury, NJ. New employees receive training and opportunities to grow as...

  • Receiving Specialist

    2 weeks ago


    Cranbury, United States A&M Industrial Supply Full time

    A&M Industrial is a 70-year-old, family-owned leading local industrial distribution company looking for career-oriented individuals to fill critical positions their warehouse logistics staff. The growth of the company has created full time opportunities in their distribution center in Cranbury, NJ. New employees receive training and opportunities to grow as...

  • Receiving Specialist

    4 weeks ago


    Cranbury, United States A&M Industrial Full time

    A&M Industrial is a 70-year-old, family-owned leading local industrial distribution company looking for career-oriented individuals to fill critical positions their warehouse logistics staff. The growth of the company has created full time opportunities in their distribution center in Cranbury, NJ. New employees receive training and opportunities to grow as...


  • Cranbury, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation. Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities. ...

  • Receiving Specialist

    1 month ago


    Cranbury, United States A & M Industrial Inc Full time

    Job DescriptionJob DescriptionDescription:A&M Industrial is a 70-year-old, family-owned leading local industrial distribution company looking for career-oriented individuals to fill critical positions their warehouse logistics staff. The growth of the company has created full time opportunities in their distribution center in Cranbury, NJ. New employees...


  • Cranbury, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation. Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities. ...