Archival Solutions Specialist - job 2 of 2

The Opportunity

This role will have a specific focus on archival solutions, including the electronic archiving application and Holly Springs records room. You will work with stakeholders site-wide at Holly Springs in relation to GxP records. Specifically, internally will liaise with Global Document Archival Manager; Manager, QualityDocs; Quality System Business Process Owners; IT Compliance; QAIT.

The incumbent will provide support to business processes, procedures, and execution of the Global Document Archival System. Additionally, you will provide support to the maintenance of global quality systems processes, procedures, and operational activities which includes, but is not limited to Archival, Document Retention, Document Management, training around archival system design, and application of Global Quality Policies & Standards. This role will support key stakeholders to ensure compliance of Seqirus programs to phase-appropriate GxPs, global legal/regulatory requirements, and applicable global Seqirus Quality Policies.

The Role

• Develops technical solutions to complex problems requiring ingenuity and innovative thinking related to the support of the commercial implementation of new drug products.

• Support improvement efforts and ongoing maintenance of Archival Systems by identifying gaps and supporting the implementation of improvements.

• Drives adoption of Archival System across the enterprise.

• Support site and function audit preparations with respect to e-Archive functionality.

• Support the development of harmonized training for the Archival System.

• Performs as a contact for technical questions relating to the business processes and use of the Archival System.

• Supports change controls related to Global Document Archival System.

• Issue and reconcile logbooks for the site.

• Review and storage of records submitted to the records room.

• Assist in searching, locating, obtaining, and distributing documents/records both onsite and offsite.

• Arrange offsite storage of records.

• Assist in filing EDMS documents.

• Processing audit and customer requests.

• Actively participate in team meetings.

• Perform as a contact for technical questions relating to document submissions to the records room and the electronic archival application. Support the development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of archival systems.

• Support the development of training for archival systems.

• Maintain system-related metrics.

• Support system improvement initiatives to optimize the business processes and practices for archival systems.

• Provide high-quality customer service and first-line archival systems support.

• Interface with other Seqirus and CSL Quality functions to share best practices and identify/ leverage opportunities across Quality systems and processes.

• Support site and function audit preparations with respect to document archival.

• Own investigation of deviations and CAPAs related to archival systems.

• Support change controls related to archival systems.

• Other job duties as needed.

Your skills and experience

• Bachelor’s degree in scientific discipline/Life Sciences preferred or equivalent experience in the biotech or pharmaceutical industry.

• General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.

• Ability to analyze issues and problem-solve to support decision-making.

• Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills.

• Ability to work independently.

• Excellent computer skills and advanced knowledge of Quality Systems.

• Direct experience with TrackWise, Documentum and/or Veeva systems, GxP Archival Systems, Microsoft Office, Word, PowerPoint, and Excel.

• Self-motivator with the ability to follow up on and complete multiple projects simultaneously.

• Highly attentive to details and able to work well as part of a team

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

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