Quality Control Managers

Waltham, MA - USA

Monthly Salary: $ 179171 - 189171

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

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.

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.

Requirements & Qualifications:

The employer requires the candidate to have a Masters 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.

Salary range: one hundred seventy-nine thousand one hundred seventy-one dollars to one hundred eighty-nine thousand one hundred seventy-one dollars per year

Applicants can send resumes to the employers address indicated above. ATTN: John Grossman or apply by email: .

Required Experience:

Manager

Quality Control ManagersJob Location: 275 Second Avenue Waltham MA 02451Telecommuting: 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.Responsibilities:Develop implement and maintain quali...

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.

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.

Requirements & Qualifications:

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.

Salary range: one hundred seventy-nine thousand one hundred seventy-one dollars to one hundred eighty-nine thousand one hundred seventy-one dollars per year

Applicants can send resumes to the employers address indicated above. ATTN: John Grossman or apply by email: .

Required Experience:

Manager