Archives Coordinator

Rochester Regional Health; York and North Yorkshire; On-site; GBP 22,000 - 28,000; Full time

Job summary

Rochester Regional Health is seeking an Archives Coordinator to support the Quality Assurance department. You will manage the controlled document and electronic archive lifecycle, ensuring accurate cataloguing, secure retention, and timely retrieval, with offsite storage transfers in line with procedures, retention requirements, accreditation standards, and regulatory rules.

The role also supports audits, quality metrics, and continuous improvement.

Qualifications

• High school diploma or GCSEs including Maths, English and Science.
• Minimum one year of relevant experience.
• Experience in Laboratory QA, a pharmaceutical organization, or a CRO is preferred.
• Knowledge of Good Clinical Practice (GCP) guidance is preferred.
• Good organizational skills.
• Good written and verbal communication skills.
• Good time management skills.
• Ability to work independently and as a team member.

Responsibilities

• Independently support QA activities to meet accreditation and regulatory requirements.
• Maintain awareness of applicable standards, laws, and guidelines.
• Contribute to SOPs, Quality Manual, and procedures.
• Manage the controlled document and archive system for accuracy and timely retrieval.
• Archive electronic and paper records per retention schedules.
• Perform quality checks of archival documentation.
• Maintain records of onsite and offsite archives.
• Run reports on archive compliance and destruction timelines.
• Support site quality metrics, audits, CAPAs, and training.
• Assist with client, regulatory, and subcontractor audits.
• Help with handling customer complaints and internal quality issues.
• Collaborate with Archivists on global archiving network.
• Participate in Continuous Professional Development.
• Carry out other duties as assigned.

Skills

Organizational skills

Written communication

Verbal communication

Time management

Independent work

Team collaboration

Education

High school diploma

GCSEs including Maths English Science

Job description

Job Title: Archives Coordinator

Department: Quality

Location: Onsite; York, UK

Hours Per Week: 37.5

Schedule: Monday - Friday, 8:00 AM - 4:00 PM

SUMMARY

The Archives Coordinator Supports the Quality Assurance department by managing the controlled document and electronic archive lifecycle, ensuring records are accurately catalogued, securely retained, retrievable, transferred to offsite storage, and managed in accordance with applicable procedures, retention requirements, accreditation standards, and regulatory requirements. The role also supports broader Quality Assurance activities, audit readiness, quality metrics, and continuous improvement.

RESPONSIBILITIES

• Independently perform a wide range of activities to support the Quality Assurance department and help achieve and maintain applicable accreditation, standards, and regulatory requirements.
• Maintain current awareness of applicable standards, laws, and guidelines.
• Provide input to the development of Quality Assurance Standard Operating Procedures and processes, the Quality Manual, and other organizational procedures and processes where required.
• Manage the controlled document and electronic archive system to ensure accurate and complete cataloguing, timely retrieval, timely transfer of documents to offsite storage, and compliance with procedural timeframes.
• Manage the document archive lifecycle, including the archiving of controlled documents, forms, templates, study-specific documentation, laboratory source data, and other records considered essential to a clinical trial.
• Manage the archiving of electronic data.
• Perform quality checks of documentation prepared for archiving to ensure records are appropriately catalogued before transfer to an offsite commercial archive.
• Maintain an internal record of archived documents held onsite and within commercial archive facilities.
• Run reports to monitor compliance with archive lifecycle requirements, including storage duration, accuracy of record descriptors, retention periods, and expiration dates for destruction of stored records.
• Support adherence to site quality metrics, including timely completion of assigned internal and vendor audits, Quality Issues, CAPAs, audit responses, and site training.
• Participate in and support client, regulatory, and subcontractor audits.
• Support processes to ensure customer complaints and internally identified Quality Issues are appropriately raised and handled.
• Assist with Lean/Six Sigma and other process improvement activities.Collaborate with Archivists across the organization to support a global archiving network where required.
• Participate in Continuous Professional Development.
• Perform other duties as assigned.

MINIMUM QUALITATIONS

• High school diploma or equivalent, or five GCSE grades C or above, including Maths, English, and Science, required.
• Minimum one year of experience in a relevant role required.

PREFERRED QUALIFICATIONS

• Experience in Laboratory Quality Assurance, a pharmaceutical organization, or a Clinical Research Organization (CRO) preferred.
• Knowledge of and demonstrated experience applying Good Clinical Practice (GCP) guidance preferred.
• Good organizational skills.
• Good written and verbal communication skills.
• Good time management skills.
• Ability to work independently and as a team member.

PHYSICAL REQUIREMENTS:

Moderate - These roles require a combination of movement and stationary work, including frequent standing, walking, and moderate lifting (up to 50 lbs.). Tasks may involve repetitive reaching, bending, pushing, or pulling, along with maintaining awareness in high-traffic or operational areas. Visual focus and spatial awareness are critical in facilities, logistics, or support settings. Emotional demands include managing interruptions, prioritizing tasks, and maintaining compliance with safety standards. Environmental exposures may include equipment noise, shared workspaces, and occasional proximity to hazardous areas. Physical capability screening may be required.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.