Company Overview:
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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