Quality Assurance Engineer I

6 hours ago

Miami, Florida, United States VIVEX BIOLOGICS INC Full time
Job Title: Quality Assurance Engineer I

Job Summary:

Vivex Biologics, Inc. is seeking a highly skilled Quality Assurance Engineer I to join our team. The successful candidate will be responsible for developing, applying, revising, and maintaining quality metrics to support areas of operations at Vivex Biologics, Inc.

Key Responsibilities:

  • Lead specific tasks or small projects and ensure their successful completion, without much guidance.
  • Initiate, lead, and/or support CAPA system items: non-conformances, deviations, corrective and preventive actions, supplier corrective actions, and complaints.
  • Collaborate with CAPA system item owners and cross-functional teams to ensure they are correctly, clearly, and completely documented in compliance with procedural and technical writing requirements.
  • Conduct data analysis and make recommendations to ensure tissue safety/quality and compliance with standards, including the disposition of nonconforming products.
  • Collaborate with cross-functional teams to provide Quality-related guidance, solve technical problems, and contribute to project milestones.
  • Conduct trending analysis of relevant Quality metrics to recommend initiatives for improvement and/or corrective actions, as applicable.
  • Support investigations and root cause analyses for quality-related issues, implementing effective corrective actions.
  • Support change control activities by providing review and feedback ensuring compliance with applicable procedures and regulations.
  • Identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively.
  • Reports out on key Quality metrics during relevant meetings.
  • Assist in the planning, development, review, implementation, and maintenance of Quality Assurance Policies and Standard Operating Procedures.
  • Ensure personal and company compliance with all federal, state, company and regulatory bodies' regulations, policies, and procedures.
  • Support validation activities, including protocol development and execution, as needed.

Requirements:

  • Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
  • At least 1 year of experience in related Engineering or Quality role.
  • Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
  • Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
  • Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs).
  • Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
  • Effective oral, written, communication, and presentation skills.
  • Strong analytical and problem-solving skills.
  • Project management skills preferred.
  • Ability to be assertive and influence others and lead significant change.

Working Conditions:

Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct Reports:

No direct reports (Individual contributor role)

Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.

Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

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