Archivist

Job Title: Archivist

Department: Quality

Location: Onsite, York, UK

Hours Per Week: 22.5

Schedule: Part-time

SUMMARY

As an Archivist within the Quality team, the Archivist will independently perform a wide range of activities to support the Quality Assurance department by participating in the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organisation.

RESPONSIBILITIES

• Independently perform a wide range of activities to support the Quality Assurance department by participating in the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organisation.

• Maintain current awareness of all required standards, laws & guidelines

• Provide input to the development of Quality Assurance Standard Operating Procedures & processes, the Quality Manual and other organisational Standard Operating Procedures & processes where required

• Manage the Controlled Document and electronic Archive system to ensure: Accurate and complete cataloguing, timely retrieval, sending documents to offsite storage, timeframes required in ACM procedures are met, provide input to the development of Quality Assurance Standard Operating Procedures & processes Manage the document archive cycle within the organisation, achieving this function by holding responsibility for the archiving of Controlled Documents such as forms, templates, study specific documentation, laboratory source data and other documentation produced within the organisation which would be considered an essential document to a clinical trial.

• Archiving of electronic data

• Quality check documentation that is prepared for archiving to ensure all documentation is catalogued at ACM Global Laboratories before sending to an offsite commercial archive.

• Maintain an in-house record of all archive documents, to allow for knowledge of documents held in house at ACM Global Laboratories and within a commercial archive 

• Run reports to ensure compliance with archiving life cycle requirements, such as life of record in storage, accuracy of descriptors of documents in storage and retention period expiration date monitoring for destruction of stored records

• Support Quality Assurance department in ensuring adherence to site Quality metrics; including: assigned internal audit & vendor audits are completed as scheduled, monitoring on time completion of QIs/CAPAs, internal & external audit responses and site training.

• Participate in and support client, regulatory and sub-contractor audits

• Support the processes in place to ensure customer complaints are appropriately raised and handled

• Support the processes in place to ensure internally identified Quality Issues are appropriately raised and handled

• Assist with Lean/Six Sigma, process improvement

• Work alongside Archivists within the organisation to form a global network of archiving (where required)

• Participate in Continuous Professional Development

REQUIRED QUALIFICATIONS

• High school diploma or equivalent, 5 GCSE Grades C or above (including Maths, English and Science) required
• Minimum 1 years’ experience in a relevant role required
   

​PREFERRED QUALIFICATIONS

• Experience in Laboratory Quality Assurance, Pharmaceutical or Clinical Research Organization (CRO) is preferred

• Knowledge of, and demonstrated experience with application of Good Clinical Practice (GCP) guidance is preferred

• Good organizational skills

• Good written and verbal communication skills

• Good time management skills

• Works independently as well as functions as a team member

PHYSICAL REQUIREMENTS:

Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer.
Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.