QA Specialist

Summary/Objective:

The QA Specialist position is responsible for the review and approval of commissioning and validation protocols to support a major biopharma client for their shutdown. In addition to protocol review/approval, protocol deviation handling and providing guidance to issue resolution is imperative.

The position is required to support a shutdown for a major biopharma client in Rockville, MD. The position can be either 1099 or W-2.

If a W-2 route is chosen, EOI Consulting provides a very competitive salary, highly subsidized medical/dental/vision benefits, matching 401K plan, paid time off, immigration sponsorship and independent work environment.

Essential Functions:

Job Description Summary

· At least 5 years of experience in a biopharmaceutical environment with expertise in Good Manufacturing Principles (GMP) and Good Documentation Practices (GDP)

· At least 5 years of experience with validation of systems utilized in biopharmaceutical manufacturing including:

o Equipment (Bioreactors, Chromatography systems)

o Automation to include code review (Delta V, Control systems)

o Utility systems (WFI, HVAC)

o Manufacturing processes

· Review and approval of validation protocols and reports (pre and post execution)

· Review and approval of deviations and lab investigations

· Experience in review of manufacturing and automation change control documentation (requirements, execution, and approval)

· Review and approval of engineering drawings, turnover packages, and release of systems, equipment

We are looking for professionals with these required skills to achieve our goals:

Bachelor’s Degree in Science, or an engineering or pharmaceutical discipline, OR equivalent body of knowledge through direct application of Quality principles in support of Good Manufacturing Practices in the biopharmaceutical industry
Experience with the application of quality systems, regulatory requirements, and industry standards
Experience with document management systems (e.g., Kneat, Veeva, SAP)
Flexible schedule with the potential for work on evenings, weekends, and holidays

If you have the following characteristics, it would be a plus:

Flexible work schedule with the ability to work independently and prioritize workload. This may include weekends, evenings and holidays.
Excellent oral and written communication skills
Strong interpersonal skills with an ability to enable and drive change
Problem identification and solving skills
Experience working with multi-functional teams

Assignment Duration:

Anticipated dates for support will be from October, 2024 through March, 2025. Work is 40-45 hours (8 hour shifts). Flexible schedule is required. Work may be across evenings, holidays and weekends. Off hour support will receive extra compensation as needed.

EOI Consulting Group, LLC

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Quality Assurance Specialist