Quality & Compliance Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee training assignments and due dates for personnel associated with Renovo and clients.

• Verify that personnel possess the appropriate training matrix for their specific role, site, and asset scope.

• Collaborate with clients and escalate any overdue training issues.

• Ensure that no individual engages in work on GxP-critical assets without current qualifications.

• Maintain qualification documentation for designated sites.

• Report any gaps in training and qualifications to the Manager of Quality and Compliance and the Site Operations Manager.

• Assist with vendor qualification and requalification by collecting evidence and conducting file completeness checks.

• Review representative samples of vendor work to ensure compliance with required certifications and training.

• Confirm that approved vendor checklists and protocols are uploaded before scheduling work.

• Evaluate completed maintenance, calibration, and repair records for compliance.

• Ensure adherence to good documentation practices, current procedures, and the qualification status of instruments and standards.

• Review GxP comments and follow up on any deviations from standard procedures.

• Rectify documentation issues prior to closeout and guide record authors.

• Examine hardcopy calibration records that are maintained outside the system of record.

• Identify and document non-conformances and coordinate quality events.

• Aid in investigations by gathering evidence, retrieving records, and reconstructing timelines.

• Monitor corrective and preventive actions until closure.

• Prepare assigned sites for audits and inspections from clients and regulatory bodies.

• Gather and organize evidence for audit and inspection responses.

• Track audit findings and observations until resolution.

• Compare documented processes against actual practices and highlight any discrepancies.

• Assist in the development and upkeep of process flows.

• Provide process training and retraining to coordinators, engineers, and analysts.

• Support Master Data Analysts in cases where record defects have compliance implications.

• Escort and host OEM and third-party personnel at client locations.

• Verify third-party induction, badging, safety, and authorization needs.

• Confirm authorized work and ensure service records are completed prior to third-party departure.

• Report any unannounced arrivals or unauthorized work activities.

• Adhere to Renovo, customer-site, OSHA, and laboratory safety protocols.

⛳️ Requirements

• Minimum of 3 years of experience in quality, compliance, regulatory affairs, or documentation review roles within a GxP environment.

• Proven experience in reviewing GxP records in accordance with good documentation practices.

• Experience in overseeing training and qualification compliance for a group.

• Background in supporting client audits or regulatory inspections.

• Working knowledge of good documentation practices, data integrity expectations, and the differences in GMP, GLP, and GCP scopes.

• Familiarity with a computerized maintenance management system (CMMS) used as a compliance record system.

• Capacity to correct a colleague’s records and provide coaching without harming the working relationship.

• Experience in pharmaceutical, biotechnology, or research environments is required.

• An Associate or Bachelor’s degree in a scientific, technical, or quality discipline is preferred.

• Equivalent experience may be considered.

• Training in GxP, data integrity, good documentation practices, and client site safety is provided or required.

• Ability to wear necessary personal protective equipment while on site.

• Willingness to travel approximately 20 to 30 percent.

• Comply with applicable customer site safety requirements, OSHA guidelines, and laboratory or facility-specific procedures.

• Complete mandatory safety training assignments punctually.

🏝️ Benefits

• Continuous training opportunities.

• Mentorship programs available.

• Supportive work culture.

• Paths for professional growth and advancement.

• Training and retraining on Renovo and client processes provided.

• Support for formal quality or compliance certification.

• CMMS and platform training offered after hiring.

• Primarily remote, office-based work environment.

• Commitment to equal employment opportunities.

• Employment is at-will.