GMP Raw Materials Quality Analyst — Sampling & Release

WuXi Biologics Group; Kentucky; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company in Ohio seeks a Raw Materials Analyst to support the sampling, labeling, testing, and release of raw materials. This role requires a Bachelor's or Master's degree in Chemistry or Biochemistry and at least two years of GMP experience. Familiarity with global regulations and pharmacopoeia documents is required. The ideal candidate should possess strong time management skills and be proficient in English and Chinese writing, operating office software. Join us in building a future together.

Qualifications

• Two years GMP working experience, ideally in raw material testing.
• Familiar with GMP regulations for raw materials in China, the US, EU.
• Experience with pharmacopoeia documents from China, the US, and Europe.

Responsibilities

• Support sampling, labeling, testing, and release of raw materials.
• Coordinate with external labs for testing and sampling activities.
• Manage raw material testing sample and documentation.

Skills

Good time management

Multi-task ability

Emergency ability

Good English writing skills

Good Chinese reading skills

Proficient in office software

Education

Bachelor or Master degree in Chemistry or Biochemistry

Job description

As a Raw Materials Analyst, you will support the sampling, labelling, testing, and release of raw materials in line with GMP standards. You will manage sample lifecycle activities, coordinate with external labs, and ensure accurate documentation and data review. The role also involves supporting investigations, maintaining compliance with global regulatory requirements, and contributing to SOPs and quality documentation, ensuring the timely release of materials for manufacturing.

Key Responsibilities:

• Serve as Raw Material analyst.
• Responsible for the raw material sampling, labelling, testing and release activities in Quality Control Department.
• Responsible for communicating with the third parties for outsourcing test and sampling, labelling and sample storage activities of raw material team.
• Responsible for raw material testing sample, backup sample and retention sample management.
• Responsible for creating and revising SOP, AMP, Material SPEC, Deviation, Change Control etc. for RM team.
• Maintain related record documentation and review analysis records of GMP testing in raw material group.
• Be responsible for handling abnormal conditions during QC raw material sampling, and write related changes, deviations and SOP.

Your Profile:

• Bachelor or Master above degree in Chemistry, Biochemistry or other related fields.
• Two years GMP working experience. Experience in raw material testing and clean area is plus.
• Familiar with the description of raw material sampling for GMP regulations in China, the United States, the European Union and other countries.
• Familiar with reading and inquiry Chinese, American and European pharmacopoeia document.
• Familiar with the regulations of sampling rule in GB and ISO.
• Good time management ability, multi-task ability and emergency ability.
• Good English and Chinese writing and reading skills, proficient in office software operation.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com . WuXi Biologics is an equal opportunities employer.