Quality Control Managers

Visterra•Waltham, MA

29d•$179,171 - $189,171•Hybrid

About The Position

Quality Control Managers Job Location: 275 Second Avenue, Waltham, MA 02451 Telecommuting: Telecommuting is available for up to 2 days a week but the candidate must reside within commuting distance of Waltham, MA to be available for in person meetings.

Requirements

The employer requires the candidate to have a Master’s degree in Chemistry; Colloids, Polymers and Surfaces; or a closely related field and at least four (4) years of work experience in any occupation performing quality control within the biopharmaceutical industry specifically with biologics.
Candidate must also have the following:
Demonstrated ability working with various QC techniques and instrumentation including SEC, icIEF, CE SDS, HPLC/UPLC, and spectrophotometry used in biologics gained through four (4) years of work experience.
Demonstrated knowledge of regulatory requirements (ICH, EMA, FDA), compendial methods, and industry standards gained through four (4) years of work experience.
Demonstrated ability working with QC software/tools such as JMP, iStability, or equivalent to analyze data gained through four (4) years of work experience.
All years of work experience may be gained concurrently.

Responsibilities

Develop, implement, and maintain quality control systems and protocols for biologics.
Ensure all QC activities are accurately and timely documented.
Develop, implement, and manage stability programs for biologics products.
Ensure stability studies are conducted according to regulatory guidelines and company SOPs.
Analyze stability data, identify trends, and report findings to senior management and relevant stakeholders.
Prepare for and participate in QA audits, contribute to regulatory updates and responses regarding stability.
Maintain up-to-date knowledge of regulatory requirements and industry best practices.
Analyze QC and stability data to identify trends, deviations, and areas for improvement.
Generate and review QC and stability reports, ensuring accuracy and completeness.
Oversee investigations into quality issues, deviations, and non-conformances at CDMOs.