Qa Documentation Review Specialist

POSITION SUMMARY:

Will review all donor records to determine eligibility of donated tissue for processing, and review documentation of actual process performed in the manufacture of any/all products to ensure compliance with all standard operating procedures (SOP’s) and applicable regulations.  Work with internal medical experts and management when necessary to receive guidance before making final decision on eligibility of donor tissue for the manufacture of product.  Verify proper labeling of tissue throughout the entire process, from recovery to release for processing. Inspect all new products and determine their acceptability for release for distribution/shipment.  Work to resolve identified errors and deviations and ensure compliance with quality system standards, policies, and procedures. Perform inventory activities as it relates to the annual financial audit.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review documentation records completed by technicians during processing of any/all products to ensure proper procedures were followed
• Identify any errors/deviations in reprocessing records and work with appropriate individual(s) to resolve, and/or submit for review/approval as needed
• Perform thorough review of all donor medical records and social histories, with emphasis on compliance to approved quality guidelines (administrative, medical, technical perspective)
• Identify and obtain necessary/missing information from all tissue recovery resources (internal and external)
• Work with external lab resources to monitor accuracy and status of tests/services requested by tissue recovery resources (internal and external); assist in resolving issues regarding requested services (e.g. type of test(s) needed, missing information on lab order form, etc.)
• Perform thorough review of tissue labels, with emphasis on compliance to approved quality guidelines
• Make final determination on eligibility of recovered tissue for processing, working with in-house medical expert as needed for clarification and guidance
• Inspect final products identified as ready for release by packaging technician to determine acceptability for distribution and shipment (e.g. product is in proper packaging, has appropriate instructions for use, correct label, untampered safety seal, etc.); compare documentation records to visual inspection of product
• Review quality control records to ensure accuracy and acceptability of analytical results including product moisture levels, and out-of-specification investigation documentation, as applicable
• Communicate inventory levels related to newly released new product and/or returned products to fulfillment departments (i.e. operations, shipping/storage)
• Ensure company-wide compliance to quality system standards and procedures; identify, recommend, and assist with the development and implementation of needed improvements
• Assist in developing and/or revising standard operation procedures, policies, and forms related to the recovery, donor suitability determination, and release of donor tissue; identify ways to improve efficiency and quality
• Review and make final decision on unsuitable tissue (deferred) and to discard as biohazardous waste

EDUCATION/EXPERIENCE:

• Bachelor’s degree preferred; or equivalent work experience.
• Specialized skill training; certification may be required
• 4+ years of experience in related area of responsibility
• Prefer experience in a Quality Assurance role within a FDA regulated environment, and knowledge of AATB

SKILLS/COMPETENCIES:

• Possesses and applies broad knowledge of principles, practices and producers of particular field of specialization, solid knowledge of technologies and practices
• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.)
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail

WORK ENVIRONMENT:

The work is typically performed in a normal office environment, processing lab, or warehouse.  Role routinely uses standard office equipment; may require use of lab equipment (i.e. refrigerator).  Will be required to comply with proper protective equipment guidelines (e.g. gloves, masks, lab coats, etc.), as applicable.  May be required to work at other office locations (within 10 mile radius).