The Archival Specialist is responsible for receiving, reconciling, scanning, uploading, reviewing and approving all paper batch records, charts and other manufacturing data. This position is responsible for archiving all paper-based documentation in the physical archival locations as well as tracking and preparing these records for transfer to the offsite storage facility.
Responsibilities and Accountabilities:
- Receives all paper batch record documentation into the Scanning Center.
- Reconciles all control printed procedures not related to process orders within the document management system and physically archives them in the Product Release records room.
- Prepares the paper documents for scanning by ensuring all staples and paperclips are removed from the documents.
- Ensures that all attachment pages have been copied, approved, and included within the document to be scanned. Ensures all documents to be scanned have process orders preceding the batch record to be scanned.
- Utilizes the document scanners and the Kofax scan solution software to scan in process order related paper batch record documents into the SAP DMS.
- Reviews each page of the scanned batch record for readability, completeness, and conformity with the original paper document. Ensure batch, material and order numbers are checked against the scanned document and the index fields on screen.
- Check scan for completeness by comparing number of pages of paper document with the electronic document. This check is completed electronically by approving via e-signature in the Kofax workflow.
- Ensures the image quality is good, the text is legible, the pages were pulled into the image straight. If any issues are noted, the entire document is scanned again. Ensure the readability of all embedded drawings, images, diagrams, labels, and charts.
- Responsible for troubleshooting the Scanners and Software and entering ITSMs as needed if the issue cannot be resolved within the Scan Center.
- Responsible for routine cleaning of the scanners to ensure high quality scanning operations are maintained.
- Responsible for preparing batch records and other archived documentation for off-site storage by tracking the location of records on the SharePoint records managements site.
- Responsible for generating and sending the monthly document reconciliation reports.
- Performs routine tasks within the QA Release Dept. including administrative duties, ordering supplies, etc.
- Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.
- Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovations, Integrity, Collaborations, and Superior Performance.
- Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties/responsibilities assigned by Sr. Management.
Qualifications:
Education: Associates degree preferably in Library sciences or High School Diploma with at least 2 years of experience in a regulated industry or in data/records archival management role.
Experience:
- Preferred experience in the field of data records management/scanning and electronic archival
- Experience in a GMP or regulated environment preferred
- Excellent computer skills
- Excellent organizational skills
- Must be able to work independently with little or no direction
- Excellent attention to detail and ability to commit/meet deadlines
- Must interact well with peers and customers
- Must be able to handle changing priorities with positive spirit
Competencies:
- Communicates effectively
- Customer focus
- Resourcefulness
- Situational adaptability
- Tech Savvy
- Optimizes work process
Working Conditions:
- Role requires extended periods of sitting and screen time
- Must be able to lift and carry document boxes >20 lbs
- Onsite required 100%
Travel Requirements:
The expected wage range for this position at hiring is $21.15/hour - $25.00/hour. Please note this wage range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
