Biopharma QC Scientist: Release & Stability Specialist

Yoh, A Day & Zimmermann Company

False Pass (AK)

Sur place

USD 4 959 000 - 5 235 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Medical, Prescription, Dental & Vision
Health Savings Account
401K Retirement Savings Plan
Direct Deposit & weekly pay
Certification and training

Résumé du poste

Yoh, a Day & Zimmermann company, is seeking a QC Scientist to test drug product and drug substance samples for release, stability, and in-process activities. The role requires solid wet-lab skills, cGMP knowledge, and experience with ELISA and cIEF assays.

You will prepare samples, maintain documentation, and support investigations and SOPs in a fast-paced GMP environment. Qualified candidates have a bachelor’s degree in a life science and at least two years’ lab experience, including

Qualifications

  • Bachelor's degree in Chemistry, Biochemistry, Biology or Microbiology or science related field.
  • Minimum 2 years of lab testing experience with cGMP knowledge.
  • Biopharmaceutical testing experience required and willingness to learn various techniques.
  • Experience with ELISA (protein A, HCP) and cIEF assays.
  • Strong understanding of cGMP and compliance guidelines.

Responsabilités

  • Perform and train others on physical testing of laboratory samples using various chemical and biochemical techniques.
  • Prepare laboratory samples, standards and solutions for analysis.
  • Manage sample lifecycle and associated documentation, both physical and electronic.
  • Author and participate in laboratory investigations and SOP updates.
  • Review and approve laboratory data and support instrument lifecycle, transfer and validation.
  • Maintain 5S and routine equipment/glassware cleaning; support continuous improvement.

Connaissances

Scientific knowledge
Lab techniques
Documentation
cGMP understanding
Biopharmaceutical testing
Assays (ELISA, cIEF)
Systems experience
Data integrity awareness

Formation

Bachelor's degree in Chemistry/Biochemistry/Biology/Microbiology

Outils

SAP/ERP
LES
WebStatistica
Empower
Hamilton
Analytical instrument software (SoftMax)

Description du poste

Yoh, a Day & Zimmermann company, is seeking a QC Scientist to test drug product and drug substance samples for release, stability, and in-process activities. The role requires solid wet-lab skills, cGMP knowledge, and experience with ELISA and cIEF assays.

You will prepare samples, maintain documentation, and support investigations and SOPs in a fast-paced GMP environment. Qualified candidates have a bachelor’s degree in a life science and at least two years’ lab experience, including

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