QC Chemist II

QC Chemist II

Thermo Fisher Scientific
2-5 years
Not Specified

Job Description

Job Description :
How Will You Make an Impact
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit www.thermofisher.com.
What will you do
Responsible for providing QC testing for GeneChip arrays in compliance with ISO 13485:2003 and 21- CFR – 820.
  • Timely review and disposition of QC batch records for release to QA.
  • Ensure sufficient resource to conduct QC testing to support array manufacturing.
  • Participate in the successful transfer of new products and ensure QC staffs are adequately trained to conduct QC testing.
  • Provide timely updates of QC test results and participate in failure analysis to support array manufacturing process.

  • Ensure timely review and disposition of QC batch records for release to QA.
  • Ensure laboratory equipment is maintained per established schedule. Manage laboratory inventory to support QC testing.
  • Participate in the development of new testing procedures/assays to support the release of new products.
  • Conduct lab investigation/trending relating to product performance failures. Identify and implement corrective and preventive actions as necessary.
  • Ensure proficiency tests are timely performed and reviewed.

Common Duties
  • Supervise the timely testing of GeneChipÒ arrays, QC/STR/PQ arrays, in conformance to established DOPs.
  • Provide guidance and training to other employees and QC Technicians / Technical Specialists as required.
  • Assist QC Section Manager in accomplishing QC tasks assigned.

How will you get there
Education and Qualifications
  • Degree in Chemistry, Biochemistry or equivalent.

  • Min 2 years QC experience in chemical handling, preferably in pharmaceutical / biotech industries
  • Proficiency in handling laboratory equipment like scanners, fluidic stations.
  • Proficiency in computer systems for laboratory test, analysis, and data management.
  • Working knowledge of cGMP and QSR preferred.

Other Essential Attributes / Competencies
  • Strong written and verbal communications skills and demonstrated ability to meet deadlines and work independently in a quick paced environment.
  • Requires strong organizational skills and attention to details.
  • Must be self-motivated, results oriented, and work well with minimal supervision.

At Thermo Fisher Scientific, each one of our 70,000 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. 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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