Job Description

Base pay range

$50.00/yr - $80.00/yr

Job Description

The Role

• The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations.
• This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.

Responsibilities:

• Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
• Provide QA review and approval for commissioning/qualification/validation documents.
• Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
• Work collaboratively with other site functions to instill a Quality Culture by coaching in the application of GMP principles including the underlying rationale of those principles.
• Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports.
• Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed.

Required Qualifications:

• B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility.
• Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
• Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects.
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
• Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
• Off hours coverage and flexibility may be required.

Preferred Qualifications:

• Experience with computer verification/validation.
• Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product).
• Experience working in a sterile fill/finish facility.

Seniority level

• Associate

Employment type

• Contract

Job function

• Engineering and Information Technology

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

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