Consultant, CQV

Quality Agents • Rockville, MD

1d • $50,000 - $105,000 • 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 Consultant builds technical skills under direct supervision and grows into independent work on standard deliverables. The Consultant acts as the technical point of contact with the client counterpart on assigned scopes. The role carries no supervisory responsibility.

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

• Ability to problem-solve and troubleshoot.
• Technical writing ability and use of Microsoft Word, Excel, PowerPoint and Project.
• 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.
• Excellent written and verbal communication skills.

Responsibilities

• Write and execute qualification protocols (IQ, OQ, PQ) for biopharmaceutical equipment, systems and support utilities in accordance with SOPs, validation master plans, regulatory expectations and industry standards.
• Conduct temperature mapping studies, including the operation of Kaye data loggers or equivalent.
• 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 closely with client site manufacturing, engineering and QA personnel to develop validation documents.
• Support commissioning and start-up activities such as system walkdowns, factory and site acceptance testing, and design and requirements reviews.
• Gain exposure to the validation aspects of facility start-up, redesign, retrofit and expansion.
• Travel to client sites and complete assigned tasks on schedule.
• 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: Entry Level