Senior Consultant, CQV
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 Role The Senior Consultant leads technical work streams with minimal oversight and carries deep expertise in one or more service areas. The Senior Consultant mentors and reviews junior staff.
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
- Lead technical work streams: plan, write, execute and close out qualification and validation packages (IQ, OQ, PQ, temperature mapping and requalification) for cGMP equipment, systems, utilities and facilities.
- Evaluate the equipment, utilities, systems and procedures used in development, production and holding of pharmaceutical products and determine the validation approach.
- Review and approve documented test results and maintain records for later analysis.
- Lead non-conformance handling, investigations and troubleshooting of equipment, utilities and systems.
- Support the validation aspects of facility start-up, redesign, retrofit and expansion, including commissioning, acceptance testing, design and requirements reviews, and traceability to user requirements.
- Coordinate validation activities with the client and meet timelines.
- Mentor junior staff and review their work.
- Travel to client sites and work independently to complete tasks.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
