Lead Consultant, CQV

Quality Agents • Rockville, MD

1d • $125,000 - $165,000 • Onsite

About The Position

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our consultants support the qualification and requalification of equipment, utilities, systems and facilities used to manufacture and test biologics and drug products at client sites and provide GMP quality assurance support to client quality organizations. Consultants work to current US and international regulations, guidance and industry best practice, coordinate activities with the client, and meet timelines. Documents prepared by Quality Agents consultants are approved by the client. Our mission is to provide cost-effective solutions by providing intelligent, driven resources to our clients, with superior quality and integrity.

The Lead Consultant manages the full project lifecycle and owns the project-level client relationship. The Lead Consultant leads project teams and coaches engineers while still doing hands-on work.

Requirements

• BS in a technical discipline (Engineering, Chemistry, Microbiology, Biology).
• Current driver's license and auto insurance, or other dependable means of transportation.

Nice To Haves

• Experience with validation equipment such as the Kaye validator, wireless data loggers or other monitoring devices is strongly desired.
• Experience using statistical tools to analyze data captured during validation studies is a plus.

Responsibilities

• Manage the full project lifecycle for qualification and validation projects: write validation master plans, coordinate project meetings related to their execution, and see packages through to closure.
• Write site-specific and multi-site validation procedures.
• Lead commissioning and qualification activities for facility, utility and equipment start-ups, from design and requirements review through acceptance testing, qualification and summary reporting.
• Write, review and execute validation plans, IQ/OQ/PQ protocols and SOPs for equipment, systems and utilities.
• Support implementation of change requests to validated systems and resolution of process deviations through technical knowledge, supporting validation studies, and review and approval of manufacturing documentation.
• Lead investigations and troubleshooting of equipment, utilities and systems.
• Own the project-level client relationship: day-to-day client interface for the project team and ongoing assessment of the client's needs on the project.
• Lead the project team: day-to-day direction, task quality and review of deliverables for everyone staffed on the project.
• Coach engineers on the team while continuing to deliver hands-on technical work.
• Travel to client sites as projects require.
• Comply with all applicable Quality Agents and client policies on health, safety and the environment.

Benefits

• Health, dental and vision insurance
• Life, AD&D and disability insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid time off
• Paid holidays
• Paid parental leave
• Incentive bonuses may be awarded depending on company profitability and individual contribution.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior