Consultant, CQV

Quality Agents • Rockville, MD

2d

About The Position

Quality Agents, LLC provides validation and quality expertise to the pharmaceutical and biotechnology industries. Consultants support 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 in accordance with current US and international regulations, guidance, and industry best practices; coordinate activities with clients; and meet timelines. Documents prepared by consultants are approved by the client.

The Consultant develops technical skills under direct supervision and progresses toward independent work on standard deliverables. The role serves as the technical point of contact with the client counterpart for assigned scopes and has no supervisory responsibility. Work includes preparing and executing qualification protocols, supporting investigations and commissioning activities, and collaborating with client manufacturing, engineering, and QA personnel. The position requires travel to client sites as projects require.

The role is full-time, W-2. Each consultant is supported by a career manager who is separate from the project lead and remains with the consultant across projects, with monthly check-ins and a yearly development plan. Salary is $50,000 to $105,000 per year, with placement based on experience and the scope of work owned. Full-time employees are eligible for benefits, subject to plan documents and eligibility requirements. Incentive bonuses may be awarded based on company profitability and individual contribution.

Requirements

• Bachelor of Science degree in a technical discipline such as Engineering, Chemistry, Microbiology, or Biology.
• Current driver's license and auto insurance, or another dependable means of transportation.
• Ability to problem-solve and troubleshoot.
• Technical writing ability and proficiency with Microsoft Word, Excel, PowerPoint, and Project.
• Excellent written and verbal communication skills.
• Typically, 0 to 4 years of experience in at least one of these areas: equipment and utility qualification, process validation, analytical method validation, or cleaning validation. The stated experience range is a guide rather than a requirement; placement depends on the scope of work the candidate can own and demonstrated performance.

Nice To Haves

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

Responsibilities

• Write and execute IQ, OQ, and PQ qualification protocols for biopharmaceutical equipment, systems, and support utilities in accordance with SOPs, validation master plans, regulatory expectations, and industry standards.
• Conduct temperature mapping studies, including operating Kaye data loggers or equivalent equipment.
• Review documented test results and maintain records for later analysis.
• Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems.
• Read P&IDs, isometric drawings, and as-built drawings.
• Work with client site manufacturing, engineering, and QA personnel to develop validation documents.
• Support commissioning and start-up activities, including system walkdowns, factory and site acceptance testing, and design and requirements reviews.
• Gain exposure to validation work for facility start-ups, redesigns, retrofits, and expansions.
• Travel to client sites and complete assigned tasks on schedule.
• Comply with applicable Quality Agents and client health, safety, and environmental policies.
• Apply feedback from reviews and support peers on shared tasks.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Life, AD&D, and disability insurance
• Health savings account for participants in the company's health plan
• 401(k) 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: Entry Level