Job Description

:
BioStem Technologies, founded in 2014 and located in South Florida, is a leading medical technology company focused on advanced wound care and regenerative medicine. We develop and commercialize placental tissue allografts, cutting-edge wound care products, and surgical solutions aimed at improving patient outcomes. As we continue our rapid growth and expansion, we seek a seasoned Medical Records Associate to join our team.

Position Summary:
The Medical Records Associates' responsibilities include maintaining and reviewing incoming tissue information, medical records and testing results while adhering to SOPs and maintaining Good Tissue Practices to ensure a consistent, quality finished product.

Essential Duties and Responsibilities:

Include but are not limited to the following, other duties may be applied;

· Adhere to Standard Operating Procedures (SOPs) and maintaining Good Documentation Practices.

· Review incoming tissue records against criteria for release to manufacturing.

· Review donor paperwork for completeness. Identify any additional or missing information and inform technicians.

· Review and maintain batch record information, including outside testing results, patient medical history, and other relevant records.

· Review and determine suitability of testing results against criteria.

· Perform in depth review of medical records related to donated tissue to determine donor eligibility and ensure quality accuracy.

· Aid in QA release of components and raw materials received as well as assist with final shipping review of released product to be distributed.

· Communicates with acquisition partners and 3rd party testing sites.

Qualifications:

Education and/or Experience

· High School Diploma or AA degree

· Knowledge of GMP and safety regulations

· Experience with AATB accreditation and/or FDA 21CFR1271 regulations preferred, but not required.

· Experience with medical records.

· Ability to communicate effectively, follow detailed directions, work independently, handle multiple tasks in a fast-paced environment.

· Proficient in Microsoft Word, Excel and Outlook.

· MasterControl Knowledge preferred, but not required.

Language Skills

· Ability to write reports in the English language.

· Ability to effectively present information and respond to questions from groups of supervisors and/or managers in the English language.

Mathematical Skills

· Ability to calculate figures and amounts such as proportions and percentages.

· Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

· Ability to solve practical problems and handle a variety of concrete variables in situations where only limited standardization exists.

· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

· Ability to define problems, collect data, establish facts, and draw valid conclusions.

· Ability to interpret an extensive variety of technical instructions.

· Strong analytical, numerical and reasoning abilities.

· Well-developed interpersonal skills.

· Participative work style.

· Ability to establish credibility and be decisive.

· Results oriented with a high level of initiative.

Certificates, Licenses, Registrations

· CTBS Certifications are desirable

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