Compliance Solution Consultant
VALOGIC BIO LLC
Summary
At VaLogic Bio, we support those in the quest for the cure. Our clients are the biotech, pharma and research labs doing work that changes lives, and our job is to keep their environments, equipment and processes compliant so their science can move forward.
Job description
We are looking for a Compliance Solution Consultant with hands-on lab experience to take ownership of our in-house lab in Frederick and support our microbiology and environmental monitoring work. You will keep our lab running smoothly day to day and head out to client sites to help collect samples.
What you will do
- Own the day to day operation of the VaLogic Bio lab, keeping it clean, organized, safe and audit ready
- Receive, log, incubate, read and track samples, and enter, trend and report microbiology and environmental monitoring (EM) results
- Review data packets for accuracy and completeness so client reports go out on time
- Manage lab supplies, media and inventory, and keep equipment maintained, calibrated and documented
- Drive continuous improvement in the lab: apply 5S and good housekeeping practices, standardize how work gets done, and suggest better ways of working
- Maintain lab SOPs, logbooks, work instructions and forms so the work is consistent and easy to repeat
- Assist with sample collection at client sites, including viable and non-viable air sampling, surface sampling and personnel monitoring, using aseptic technique, chain of custody and GMP documentation practices
- Travel to and from client sites in the region as scheduled
- Cross train across service lines and support teammates wherever help is needed
- Represent VaLogic Bio with professionalism and a customer first attitude
- Perform all other duties as assigned
What you bring
- Hands-on laboratory experience, ideally in microbiology, environmental monitoring, or a GMP/GLP regulated setting
- Experience keeping a lab organized and running, including inventory, equipment upkeep and lab documentation
- A degree in microbiology, biology, or a related science, or equivalent hands-on experience
- Working knowledge of aseptic technique and good documentation practices
- A naturally organized, detail minded approach and a habit of improving how things get done
- Comfort working independently, both in our lab and at client sites, and as part of a team
- Willingness to cross train and learn new skills
- A valid driver's license, reliable transportation, and the ability to travel to client locations
- Clear communication with clients and coworkers
Nice to have
- Cleanroom gowning experience
- Experience with EM software, LIMS, or electronic quality systems
- Familiarity with USP , USP , ISO 14644 or EU GMP Annex 1
Qualifications
- Bachelor's degree in a science, engineering or technical field, or equivalent combination of education and experience
- 1 to 3 years of experience in a GMP, GLP or other regulated environment, or in the assigned service line
- Working knowledge of good documentation practices and regulated industry expectations
- Strong attention to detail and organization
- Clear written and verbal communication skills
- Ability to work independently at client sites and as part of a team
- Proficiency with Microsoft Office and the ability to learn company systems
- Valid driver's license, reliable transportation, and ability to travel to client sites
Preferred
- Experience in more than one VaLogic Bio service line
- Industry certifications relevant to the service line (for example NEBB, CETA or NSF for certification work)
- Familiarity with standards relevant to the assigned work, such as 21 CFR Parts 11, 210 and 211, ISO 14644, ISO/IEC 17025, USP chapters or GAMP 5
Requirements
- Bachelor's degree in a science, engineering or technical field, or equivalent combination of education and experience
- 1 to 3 years of experience in a GMP, GLP or other regulated environment, or in the assigned service line
- Working knowledge of good documentation practices and regulated industry expectations
- Strong attention to detail and organization
- Clear written and verbal communication skills
- Ability to work independently at client sites and as part of a team
- Proficiency with Microsoft Office and the ability to learn company systems
- Valid driver's license, reliable transportation, and ability to travel to client sites
- Hands-on laboratory experience, ideally in microbiology, environmental monitoring, or a GMP/GLP regulated setting
- Working knowledge of aseptic technique
Benefits
- Unlimited PTO
- Training & cross-training
- ISO-certified quality culture
Company overview
VaLogic Bio LLC is a specialized GMP/GxP compliance and technology solutions provider serving the life sciences industry since 2001. Headquartered in Frederick, Maryland with additional offices in Texas and Massachusetts, the company offers comprehensive advisory, consulting, and compliance services designed to simplify regulatory complexities and promote innovation for biotechnology, pharmaceutical, and life science organizations. Their expertise spans consulting, software-as-a-service (SaaS) solutions, laboratory services, and certification programs, with their flagship LogiPoint® facility monitoring system providing real-time environmental monitoring for critical facilities. The company's service portfolio includes cleanroom certifications, biological safety cabinet testing, HEPA filter integrity testing, temperature mapping, calibration services, and validation programs. As a veteran-owned business with over 150 years of collective expertise among department directors, VaLogic Bio has worked with more than 400 biotech companies of all sizes, helping them navigate FDA regulations and achieve operational excellence while maintaining compliance with GMP standards.