Quality & Compliance Specialist

Renovo Solutions; United States; Hybride; USD 75 000 - 110 000; Plein temps

Résumé du poste

Renovo Solutions seeks a Quality and Compliance Specialist to oversee ELIS program compliance at assigned sites. The role ensures trained and qualified personnel, qualified vendors, and documentation that withstands client audits or regulatory inspections.

GxP‑critical asset maintenance records must meet documentation standards, with corrections made before closeout and deviations raised when needed. This highly detail‑driven position emphasizes training, audits, and process integrity across

Qualifications

• 3+ years of experience in quality, compliance, regulatory affairs or a documentation review role in a GxP environment.
• 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 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 without damaging working relationships.
• Experience in a pharmaceutical, biotechnology or research environment.

Responsabilités

• Monitor training assignments and due dates for Renovo personnel at assigned sites, covering both Renovo-assigned and client-assigned training.
• Confirm each person holds the correct training matrix for their role, site and asset scope.
• Coordinate with the client to keep training current and escalate before due dates.
• Ensure no one on a GxP asset works without current qualification.
• Maintain qualification evidence for assigned sites for inspections.
• Report training and qualification gaps to the Manager, Quality and Compliance and to Site Operations Manager.
• Support vendor qualification and requalification with evidence collection and file completeness checks.
• Perform compliance checks on a sample of vendor work to verify required certifications and training.
• Raise vendor work without qualification evidence and do not close as acceptable.
• Review completed maintenance, calibration and repair records for compliance.
• Confirm good documentation practice and correct procedure versions are used.
• Verify instrument and standard qualification status before work.
• Follow up on GxP comments and correct documentation defects before close out.

Connaissances

Attention to Detail

Coaching

Communication

Integrity

Follow-through

Compliance

GxP knowledge

Formation

Associate or Bachelor’s degree preferred

Outils

CMMS

Description du poste

Why Renovo?

Renovo Solutions is a nationwide healthcare and life sciences technology management company. We offer a range of opportunities for employees to grow within the company. With a presence in 40+ states and a growing international footprint, we provide comprehensive solutions for managing and maintaining the equipment our clients depend on. We prioritize investing in our employees’ development, offering various phases and advancement paths. Through ongoing training, mentorship programs, and a supportive work environment, we foster professional growth and promote from within. Join our team to make a difference while advancing your career with Renovo.

Summary:

The Quality and Compliance Specialist does the compliance work on the Enterprise Laboratory Instrument Services (ELIS) program at assigned sites. This is a compliance role first. Most of the job is confirming that the people doing the work are trained and qualified for it, that the vendors performing work are qualified to perform it, and that the records produced will hold up to a client audit or a regulatory inspection.

A large share of the instrument estate on this program is GxP critical. Every scheduled maintenance, calibration and repair on those assets produces a record that has to meet good documentation practice, show the current procedure version was followed, and show that the person performing the work and the standards they used were qualified at the time. This role checks that, corrects it before close out where it is wrong, and raises a deviation where it cannot be corrected.

What you will do:

Training and qualification compliance, the core of the role:

• Monitor training assignments and due dates for Renovo personnel at assigned sites, covering both Renovo-assigned and client-assigned training.
• Confirm each person holds the correct training matrix for their role, site and asset scope.
• Chase individuals and coordinate with the client to keep training current, and escalate before a due date passes.
• Check that nobody at an assigned site performs work on a GxP critical asset without current qualification.
• Maintain the qualification evidence for assigned sites so it can be produced on demand during an inspection.
• Report training and qualification gaps to the Manager, Quality and Compliance and to the Site Operations Manager.

Vendor compliance checks:

• Support vendor qualification and requalification with evidence collection and file completeness checks.
• Perform compliance checks on a representative sample of vendor work to confirm the personnel held the certification and training required.
• Confirm pre-approved vendor maintenance checklists and protocols are loaded into the system of record before the work is scheduled.
• Raise vendor work performed without qualification evidence immediately, and do not close it as acceptable.

Work order and documentation review:

• Review completed scheduled maintenance, calibration and repair records at assigned sites for compliance.
• Confirm good documentation practice is upheld and the current version of the procedure was used.
• Check the qualification status of instruments and standards used during work on GxP critical assets, before the work rather than after.
• Review GxP comments in the system of record and follow up where a standard procedure could not be followed.
• Correct documentation issues before close out, and coach the person who produced the record so the same defect does not recur.
• Perform review of hardcopy calibration records where the site holds them outside the system of record.

Deviation support:

• Raise and document non-conformances, including cases where GxP requirements were not met during maintenance, calibration or repair.
• Coordinate non-conformances and out-of-specification events with the relevant client department or site.
• Support quality investigations with evidence gathering, record retrieval and timeline reconstruction.
• Track corrective and preventive actions assigned to the assigned sites through to closure.

Audit and inspection support:

• Prepare assigned sites for client and regulatory inspections and audits.
• Retrieve and assemble evidence during audit and inspection response.
• Support the periodic services quality review for assigned sites.
• Track audit findings and observations for assigned sites through to closure.

Process and documentation support:

• Check that documented processes at assigned sites match actual practice, and flag where they do not.
• Support process flow creation and maintenance.
• Deliver training and retraining on Renovo and client processes to coordinators, engineers and analysts at assigned sites.
• Support the Master Data Analysts where a record defect has a compliance consequence.

Escort and vendor hosting when on site:

• Escort is a standing expectation of every role on this program. When present at a client site, escort and host OEM and third‑party personnel on request, regardless of whose scope the instrument sits in.
• Confirm third‑party personnel are inducted, badged, and compliant with client site access and safety requirements before they enter a laboratory.
• Confirm the work performed matches what was authorised and the service record is complete before the third party leaves site.
• Escalate immediately where a third party arrives unannounced or attempts work outside the authorised scope.

Qualifications:

• 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.

Education/Special Training:

• 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.
• CMMS and platform training provided after hire.
• Formal quality or compliance certification supported.

Required Competencies:

• Attention to Detail - notices the procedure version that is out of date before the record is closed.
• Compliance Backbone - raises the gap rather than accepting a record that does not meet the standard.
• Coaching - corrects the person as well as the record, so the defect does not recur.
• Follow-through - chases the training due date and the open finding rather than reporting them.
• Practicality - knows the difference between a real compliance risk and a paperwork preference.
• Communication - explains a compliance requirement to an engineer in terms they can act on.
• Integrity - can admit mistakes, is direct and truthful, and acts in the best interest of clients, employees and Renovo.

Success Measures:

• Quality events closed without escalation to a KPI 3 determination. KPI 3 carries a $500,000 penalty per product‑related corrective and preventive action miss and sits outside the annual deduction cap.
• Training currency at assigned sites, measured as assignments completed by due date
• Personnel performing GxP work without current qualification at assigned sites, target zero
• Vendor compliance sample checks completed on cycle
• Documentation defects caught and corrected before close out rather than after
• Repeat documentation defects by individual, trending down
• Non‑conformances raised promptly and documented completely
• Audit and inspection findings at assigned sites, and findings closed to date
• Periodic services quality review support delivered on cycle
• Process documentation at assigned sites current against actual practice

Safety Requirements:

• Abide by and follow Renovo safety policies, procedures, and injury and illness prevention expectations.
• Maintain a safe working environment for self and others when visiting customer sites, laboratories, offices, or operational environments.
• Follow applicable customer site safety requirements, OSHA guidelines, and laboratory or facility‑specific procedures as required.
• Complete required safety training assignments on time.

Physical Requirements:

• Predominantly remote, office‑based work.
• When on assigned client sites, presence in active laboratory environments including areas with biological, chemical, electrical and cryogenic hazards.
• Ability to wear required personal protective equipment when on site.
• Travel approximately 20 to 30 percent, covering assigned sites for documentation review, audit preparation, training delivery and coaching.

Classification:

FLSA: Exempt

RENOVO Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, RENOVO Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Employee is an at‑will employee, and this does not act as a contract of employment.