Quality & Compliance Specialist

We need to output HTML fragment with sections: About the role? The posting includes "Why Renovo?" and "Summary:" etc. We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We need to parse content: The posting includes: - Why Renovo? (company description) could be "About the role"? Actually "Why Renovo?" is about company, not role. Could map to "About the role"? Might be better to treat as "About the role" includes description of role and company? The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections have content. We have: - Summary: description of role (Quality and Compliance Specialist does compliance work...). That's about the role. So we can put that under

About the role

. - "What you will do:" list of duties: training and qualification compliance, vendor compliance checks, work order and documentation review, deviation support, audit and inspection support, process and documentation support, escort and vendor hosting. That's responsibilities. So

Responsibilities

with

• items. - Qualifications: bullet list: 3+ years experience..., demonstrated experience..., experience monitoring..., experience supporting..., working knowledge..., experience with CMMS..., ability to correct..., experience in pharma/biotech/research required. That's qualifications. So

  Qualifications

  . - Education/Special Training: Associate or Bachelor’s degree preferred..., training in GxP..., CMMS training provided after hire, formal quality or compliance certification supported. That could be under Qualifications or maybe Skills? But we have Skills section maybe for competencies. The posting includes "Required Competencies:" list of competencies (Attention to Detail, Compliance Backbone, Coaching, Follow-through, Practicality, Communication, Integrity). Those are skills/behaviors. So we can put those under

  Skills

  . - Success Measures: list of metrics. Could be under Requirements? Not exactly. Could be under Requirements? Might be considered "Requirements" but we already have Qualifications. Could treat Success Measures as part of Requirements? But the instruction says include a section only when posting has real specific content. Success Measures is specific content; we could put under

  Requirements

  maybe? However Requirements often refers to mandatory qualifications; but we already have Qualifications. Could also put Success Measures under

  Requirements

  as performance expectations. Might be okay. - Safety Requirements: separate bullet list. Could be under

  Requirements

  as well, but we already might have Requirements. Could combine safety and success measures under Requirements? Might be too thin. Better to have separate sections: maybe "Requirements" for success measures and safety? But we need to avoid thin sections. Could combine safety and success measures into one Requirements section with two sub-lists? But we must use
  • for any list. Could have multiple
    inside section. We also have Physical Requirements, Classification, FLSA, Note, EEO Statement etc. Those are boilerplate; we should remove EEO, legal, etc. Also remove "Note: This position description does not list every activity..." maybe boilerplate; but it's somewhat generic; we can drop it. Also "Classification: FLSA: Exempt" maybe minor metadata; we can fold into a short

    or drop. Probably drop. We also have "Why Renovo?" which is company description; could be part of About the role? Might be better to have a separate section "About the company"? Not in allowed headings. So we can incorporate into About the role

    describing Renovo and role. Thus sections: - About the role: includes Why Renovo? and Summary. - Responsibilities: What you will do. - Qualifications: Qualifications bullet list. - Skills: Required Competencies. - Requirements: Success Measures + Safety Requirements + Physical Requirements? Might be okay. We need to ensure we don't include headings with filler text. All sections have content. We must not repeat job title as heading. Not include Job ID etc. We must not include boilerplate like EEO, legal, etc. We need to preserve all substantive information. Let's extract content precisely. About the role: "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." Then "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." Combine into a

    maybe two paragraphs. Responsibilities: list from "What you will do:" includes several sub-sections each with details. We need to capture all details as list items? Could break each major duty as

    • with sub-detail maybe as sentences inside
    • . The instruction: Use
      • for any list of duties/requirements/benefits. So we can make each duty a
      • and include the detailed sentences inside. Thus: - 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: list: - 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: Could be part of Qualifications or separate. Since we have Qualifications section, we can include education as part of Qualifications
        as well. But we might want to keep Qualifications strictly experience; but we can include education as part of Qualifications. The instruction: Use
        • for any list of duties/requirements/benefits. So we can include education items as
        • under Qualifications. Thus Qualifications list includes: - 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. Skills: Required Competencies list: - 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. Requirements: Success Measures list: - 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 -