QC Associate II, Raw Materials Specialist

3 weeks ago


Westborough, Massachusetts, United States Astellas Pharma Full time

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.

We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.

Our team is driven to develop and deliver innovative and effective new medicines to patients and physicians.

We are seeking a highly motivated individual with strong organizational skills to join us as a QC Analyst II, Raw Materials.

This position provides Quality Control compliance and release testing of raw materials used in the manufacture of Astellas cell therapy products in accordance with GDP/GMP guidelines.

The QC Analyst II, Raw Materials will be responsible for performing routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures.

The position also involves performing validation/verification of analytical methods used in RM testing, providing support and oversight of laboratory equipment, computer systems and PM/calibration program to ensure on-time testing completion.

The successful candidate will have a B.S. degree in Biology or other life science related degree with 3 + years of relevant industry experience in a quality control role, or MS with 0-2 years of laboratory experience.

Knowledge of GMP, SOP's and quality control process is required, as well as strong written and verbal communication skills.

The ideal candidate will be able to work weekends while rare, may be required, and have an understanding of quality operations with ability to troubleshoot and solve technical problems.

Experience with ICH, USP, EP and JP guidelines for test methods, 21CFR Part 11 Compliance, and Good documentation, data organization, Detail oriented, and willingness to learn are preferred.

The successful candidate will be able to excel in a fast-paced team environment, handle multiple tasks concurrently, and in a timely fashion, and have strong interpersonal skills, highly collaborative within a multi-disciplinary team and contribute to a supportive and positive work environment.

Astellas is committed to equality of opportunity in all aspects of employment.



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