Consultant, CQV

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.

• 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.

Performance at Quality Agents is reviewed on six dimensions. For this role they look like this:

• Technical Expertise:
  Protocols, reports and quality records prepared to the required standard with guidance, moving toward right-first-time execution.
• Regulatory Judgment and Risk Ownership:
  Applies cGMP requirements in day-to-day work and raises issues and risks promptly to the project lead.
• Delivery Scope and Complexity:
  Completes assigned tasks on schedule and grows into independent ownership of standard deliverables.
• Client Interaction and Influence:
  Serves as a reliable technical point of contact for the client counterpart on assigned scopes.
• Leadership and People Development:
  Takes review feedback on board, applies it, and supports peers on shared tasks.
• Commercial Awareness:
  Understands how the quality and timeliness of assigned work support the client relationship.

• 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.

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

Typically, 0 to 4 years of experience in at least one of the following areas: equipment and utility qualification, process validation,…