Job description

QC Manager / Method Steward

Direct Hire, Salary TBD

100% Onsite in Lexington, MA

***Please note, candidates applying for this role need 8 - 10 years of validation experience and a full understanding of cGMP regulations.

Summary: This successful candidate will be responsible for assisting the Sr. Validation Manager in completion of all project milestones as well as manufacturing support. This includes performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, preparation of cGMP materials and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments).

Key Responsibilities:

• Balance workload of and motivate direct reports and/or contract staff to accomplish department goals and objectives
• Manage protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
• Review and approve qualification documentation on behalf of the validation
• Ensure performance of all qualification activities is in accordance with local procedures, industry and regulatory guidance.
• Support investigations into protocol nonconformances and site
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Author standard operating procedures related to validation
• Support the execution and generation of formal risk
• Support the generation and implementation of validation
• Represent the validation department at team
• Provide technical assistance and handle any questions or concerns from regulatory agency representatives in reference to validation of site equipment, utilities and facilities, and process validation
• Supervise contract staff as

Experience needed:

• A Bachelor's degree in in Life Sciences or Engineering
• A minimum of 10 years of Validation experience is desired though less experienced candidates will be considered based upon educational level and prior work histories and supervisory experience.
• Understanding of cGMP regulations
• Technical writing ability
• Familiarity with Microsoft Office
• Experience in supervising contract personnel
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Ability to manage multiple activities with challenging timelines
• Attend meetings where required and provide subject matter expertise as applicable on the specifics of the deliverables

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.

Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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