Document Scanning Technician
Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 30 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients' needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique's experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique's unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.
The Document Scanning Technician will be responsible for digitizing and archiving paper documents for a departmental digitization initiative. This role requires a meticulous and organized individual with a strong attention to detail and a commitment to maintaining data integrity and confidentiality in accordance with Good Manufacturing Practice (GMP) and standard operating procedures (SOPs). The successful candidate will prepare physical files, operate high-speed scanning equipment, and ensure that all digital records are accurate, accessible, and easily retrievable for audit and inspections.
Key Accountabilities and Responsibilities:
- Document Preparation: Prepare physical files for scanning by removing staples, paper clips, and bindings. Organize documents according to established guidelines and batch them for efficient processing.
- Scanning and Digitizing: Operate high-speed document scanners and related software to convert large volumes of physical files into digital files.
- Perform regular quality checks on all scanned images to ensure legibility, clarity, and completeness, of the digital images. Re-scan documents as needed to meet quality standards.
- Indexing and Categorization: Accurately index and categorize digital files using established naming conventions and procedures.
- Data Integrity: Verify that all data from scanned documents is accurately captured, ensuring the integrity of the digital archive in accordance with GMP requirements.
- Workflow Management: Track project progress and maintain organized workflows to meet deadlines and project goals.
- Confidentiality and Security: Handle confidential and sensitive documents in accordance with all departmental policies and legal requirements.
- Original Document Handling: After scanning and quality assurance are complete, prepare original documents for shipping to offsite storage.
- Support QA functions by maintaining spreadsheets, tracking sheets, and checklists as it relates to digitalization.
- Identify opportunities for process improvement with the document imaging and management workflow.
- Perform additional related duties as assigned.
Additional Accountabilities and Responsibilities:
- Work independently and proactively.
- Promote process improvement.
- Ability to manage multiple competing priorities with successful follow-through and timely delivery.
- Keep manager proactively informed of progress.
- Communicate effectively and professionally with colleagues to achieve assigned tasks and goals.
- Perform job responsibilities as directed and completes tasks as assigned.
Requirements:
- High school diploma or equivalent.
- Proficient in basic computer skills and office software such as Microsoft Office Suite and Adobe Acrobat.
- Familiarity with scanning software and electronic document management systems (EDMS) is preferred.
- Prior experience with high-speed scanners is preferred.
- Attention to detail and a high level of accuracy is required.
- Excellent organizational and time management skills.
- Ability to work independently with minimal supervision while meeting productivity goals.
- Commitment to maintaining the confidentiality of sensitive information.
- Ability to sit or stand for extended period of times while operating scanning equipment.
- Ability to lift and move boxes of documents up to 50 pounds is required.
- Manual dexterity for preparing documents and operating equipment.
Compensation and Shift Information:
- The base compensation range for this role is between $18.00/hr - $18.50/hr.
- This is a temporary, part-time position and is up to 20 hours per week.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.