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:
· 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.