Compliance Solution Specialist

VALOGIC BIO LLCFrederick, MD
$22 - $30Onsite

About The Position

VaLogic Bio provides crucial technology and compliance services to clients in the life sciences and biotechnology industries, helping organizations establish and remain FDA compliant. Our client services allow scientists to focus their time on the advancement of life-enhancing therapeutics. We deliver this through a suite of services that includes advisory and facility design, equipment calibration and validation, commissioning, preventative maintenance, laboratory and cleanroom environmental monitoring, and SaaS technology for compliance and continuous monitoring. Our vision is to become the nation's premier single-source biopharma solution provider. Our mission is to support those on the quest for a cure. VaLogic Bio is hiring a Compliance Solutions Specialist (CSS) to deliver hands-on laboratory and cleanroom environmental monitoring services at customer sites. This is the primary focus of the role, and the CSS is also trained to support our other service lines — calibration, validation, certification, and maintenance — as customer needs require. This opening is at Level 1 on a career ladder that runs through Level 4. Experienced candidates are encouraged to apply, and we provide full on-the-job training for candidates who are new to the field. This is a field-based role delivering laboratory support and environmental monitoring services, with cross-training in adjacent service lines such as certification, calibration, temperature mapping and other validation activities, and preventive maintenance.

Requirements

  • High school diploma or equivalent.
  • No prior industry experience required — training is provided.
  • Working knowledge of GxP and data integrity principles, or the aptitude and willingness to learn them through our training program.
  • Excellent attention to detail and reliable execution of structured technical work.
  • Professional written and verbal communication skills.
  • Ability to travel to customer sites and maintain a customer-ready professional presence.

Nice To Haves

  • Prior experience in laboratory or cleanroom environmental monitoring strongly preferred.
  • Exposure to aseptic technique, viable and non-viable sampling, or cleanroom certification.
  • Prior experience in equipment calibration or validation is a plus.
  • Prior experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.

Responsibilities

  • Perform laboratory and cleanroom environmental monitoring at customer sites, including viable and non-viable air sampling, surface sampling, particle counting, and cleanroom certification activities, per VaLogic Bio SOPs and customer requirements.
  • Provide on-site laboratory support, including sample handling and logging, equipment operation, and routine preventive and corrective maintenance of monitored equipment.
  • Support calibration, certification, and validation activities as assigned across our service lines.
  • Maintain accurate, contemporaneous, attributable, legible, and original documentation that meets ALCOA+ data integrity standards.
  • Communicate professionally and clearly with customer personnel on site; escalate appropriately.
  • Identify and report compliance risks, deviations, and out-of-specification results promptly.
  • Complete required training and competency assessments on schedule.

Benefits

  • Medical & prescription coverage
  • Dental coverage
  • Vision coverage
  • Health Savings Account (HSA)
  • Basic Life and AD&D
  • Supplemental Life and AD&D
  • Short- and long-term disability
  • Employee Assistance Program
  • Unlimited Paid Time Off
  • 11 paid company holidays
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