Quality & Compliance Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Renovo Solutions

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2009

🏥 Healthcare

☁️ SaaS

💰 Private equity on 2022-02

Healthcare • SaaS

Renovo Solutions is a company that provides healthcare and life sciences asset management and technology management services. They offer Healthcare Technology Management (HTM) services including clinical engineering, clinical asset management, cybersecurity, technology solutions (with branded tools RENOVOLive® and RENOVOSecure), staffing, and consulting. In life sciences they provide laboratory asset management, lab operations & compliance, technology & IT services, lab relocation services, and lab sustainability practices. The company emphasizes improving equipment uptime, regulatory compliance, and operational efficiency, and reports managing over 2. 1 million assets. Headquarters in Irvine, CA, with customer service and equipment service phone numbers listed.

📋 Description

• Monitor training assignments and due dates for Renovo and client-assigned personnel • Confirm personnel hold the correct training matrix for their role, site and asset scope • Coordinate with clients and escalate overdue training • Ensure no one performs work on GxP-critical assets without current qualification • Maintain qualification evidence for assigned sites • Report training and qualification gaps to the Manager, Quality and Compliance, and Site Operations Manager • Support vendor qualification and requalification through evidence collection and file completeness checks • Check representative samples of vendor work for required certifications and training • Confirm approved vendor checklists and protocols are loaded before work is scheduled • Review completed maintenance, calibration and repair records for compliance • Verify good documentation practice, current procedures, and qualification status of instruments and standards • Review GxP comments and follow up on deviations from standard procedures • Correct documentation issues before closeout and coach record authors • Review hardcopy calibration records held outside the system of record • Raise and document non-conformances and coordinate quality events • Support investigations through evidence gathering, record retrieval and timeline reconstruction • Track corrective and preventive actions through closure • Prepare assigned sites for client and regulatory audits and inspections • Retrieve and assemble evidence during audit and inspection response • Track audit findings and observations through closure • Check documented processes against actual practice and flag discrepancies • Support process-flow creation and maintenance • Deliver process training and retraining to coordinators, engineers and analysts • Support Master Data Analysts where record defects have compliance consequences • Escort and host OEM and third-party personnel at client sites • Confirm third-party induction, badging, safety and authorization requirements • Verify authorized work and complete service records before third parties leave • Escalate unannounced arrivals or unauthorized work • Follow Renovo, customer-site, OSHA and laboratory safety requirements

🎯 Requirements

• 3+ years of experience in quality, compliance, regulatory affairs or a documentation review role in a GxP environment • Demonstrated experience reviewing GxP records against good documentation practice • Experience monitoring training and qualification compliance for a group of people • Experience supporting client audits or regulatory inspections • Working knowledge of good documentation practice, data integrity expectations, and GMP, GLP and GCP scope differences • Experience with a computerized maintenance management system (CMMS) as a compliance record system • Ability to correct a colleague’s record and coach them on it without damaging the working relationship • Experience in a pharmaceutical, biotechnology or research environment required • Associate or Bachelor’s degree preferred, in a scientific, technical or quality discipline • Equivalent experience considered • Training in GxP, data integrity, good documentation practice and client site safety provided or required • Ability to wear required personal protective equipment when on site • Ability to travel approximately 20 to 30 percent • Follow applicable customer site safety requirements, OSHA guidelines, and laboratory or facility-specific procedures • Complete required safety training assignments on time

🏖️ Benefits

• Ongoing training • Mentorship programs • Supportive work environment • Professional growth and advancement paths • Training and retraining on Renovo and client processes • Formal quality or compliance certification supported • CMMS and platform training provided after hire • Predominantly remote, office-based work • Equal employment opportunities • At-will employment