Quality Control Technician - Pompano Beach, Florida

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Job Type

Full-time

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

The Quality Control (QC) Technician is responsible for performing routine quality control activities in a tissue processing facility to ensure compliance with regulatory requirements and internal quality standards. This role includes environmental monitoring, analytical testing, performing quality control checks on 100 % of manufactured units, and preparation of samples for third-party testing. The QC Technician is expected to uphold and comply with all applicable regulations governed by the U.S. Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB).

Essential Duties & Responsibilities:

• Perform environmental monitoring in controlled cleanroom environments, including surface, air, and personnel sampling.
• Conduct moisture content testing using in-house methods.
• Perform unit inspections to verify product labeling, packaging integrity, and conformity to specifications.
• Complete and verify quality records, logs, and checklists in alignment with GDP (Good Documentation Practices) and internal SOPs.
• Prepare samples for submission to third-party laboratories for required testing.
• Participates in a variety of verification activities.
• Support and comply with all regulatory requirements, including standards defined by the FDA and AATB.
• Participate in internal quality audits, investigations, and implementation of CAPAs.
• Collaborate with cross-functional departments (operations, QA, etc.) to support quality objectives.
• Maintain a clean, safe, and compliant workspace in accordance with facility and regulatory standards.
• Perform other duties as assigned.

Requirements

Qualifications:

Education:

• High School Diploma or equivalent
• Bachelor's Degree in a scientific field (e.g., Biology, Chemistry) preferred.

Experience:

• Minimum 1 year of experience in a laboratory or manufacturing environment.
• Experience in a regulated tissue banking, biotech, medical device, or pharmaceutical setting preferred.
• Working knowledge of FDA and AATB regulatory standards is highly desirable.
• CTBS Certification preferred.

Technical Skills:

• Proficient in Microsoft Office (Word, Excel, Outlook).
• Familiarity with GDP, SOPs, and regulated documentation processes.
• Ability to perform accurate mathematical calculations, including fractions, decimals, ratios, and percentages.
• Mastercontrol experience

Interpersonal Skills:

• Strong written and verbal communication.
• Excellent problem solving and analytical abilities.
• Team oriented with ability to work independently and collaboratively.
• Strong attention to detail and high personal integrity.
• Results driven with the ability to adapt and prioritize in a fast-paced environment.

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Physical Requirements:

• Must be able to lift 10 lbs. routinely, and up to 40 lbs. occasionally.
• Ability to stand, walk, bend, and climb stairs regularly.
• Must always wear appropriate Personal Protective Equipment (PPE), including:
• Closed toe shoes.
• Gloves, gowns, sleeves, aprons, and other PPE depending on area-specific requirements.

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Work Environment:

• Exposure to cleanroom and laboratory settings.
• Routine handling of human tissue and regulated materials under controlled conditions.
• Adherence to aseptic technique and contamination control required.

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Additional Information:

• May require occasional weekend or holiday shifts based on operational demands.
• Commitment to maintaining ethical standards and regulatory compliance for tissue safety and traceability is essential.

BioStem Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The above assignments are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exclusive list of all responsibilities, duties and skills required. At the discretion of Management, Other duties and project may be assigned.