Quality Assurance Supervisor

Quality Assurance Supervisor Hemarus Plasma LLC Lauderhill and Miami Location - 2.0 Miami, FL Job Details Full-time $27 - $35 an hour 2 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Biology Production deviation management High school diploma or GED Quality assurance Attention to detail Quality control Quality audits Quality systems Associate's degree

Full Job Description Position:

Quality Assurance Supervisor Location:

This position will provide quality assurance support across multiple sites, specifically our locations in Lauderhill and Miami. The ideal candidate must be flexible and able to travel between both facilities.

Reports to:

Center Director, Corporate Quality Manager and Quality Assurance & Regulatory Affairs Official Department:

Quality Control & Assurance Status:

Hourly/Non-Exempt or Contract Summary:

Under the supervision of the Center Director and Corporate Quality Manager, in compliance with the Hemarus Quality Manual ensure center compliance with the Hemarus Standard Operating Procedures (SOP), current state and federal regulations; the Quality Assurance Supervisor is responsible for supporting and maintaining the quality systems at the plasma center. This role ensures compliance with all applicable regulatory standards, including FDA and cGMP requirements, while promoting a culture of quality and continuous improvement.

Duties and responsibilities:

1. Maintain certification and annual re-certification requirements of the Hemarus training program. 2. Conduct routine internal audits of donor eligibility, plasma collection, processing, and storage procedures. 3. Monitor deviations by tracking and trending errors and in conjunction with other QA team members and management team address areas of non-compliance by creating correct action plan. 4. Ensure compliance with FDA, cGMP, OSHA, and company policies 5. Conduct training sessions and maintain all training records in an organized manner and ensure completeness. 6. Perform weekly observations of the employees and oversee training and safety programs. 7. Review plasma shipment for conformance to SOP and customer requirements and release material. 8. Track and trend QA errors, omissions, incidents, investigate deviations, discrepancies, and non-conformances; support corrective and preventive actions (CAPA) Perform root cause analysis and corrective action plans. 9. Inspect supplies and materials for compliance prior to release for use. 10. Review and assist in equipment maintenance, calibrations and validations for accuracy and completeness. 11. Attend and assist in all external inspections. Write and submit responses to observations and CAPA with assistance from Center Director and Corporate Officials. 12. Ensure facility cleanliness. 13. Assure CLIA compliance by reviewing proficiency and reagent testing logs. 14. Ensure most current SOP's, QM, OSHA, CLIA etc manuals and forms are in the center and consistently followed. 15. Ensure concurrent, legible and accurate documentation.

Educational Requirements:

1. High school diploma or GED required; Associate or Bachelor's degree in Biology, Chemistry, or related field preferred. 2. Knowledge of FDA regulations, cGMP, and quality systems strongly preferred. 3. Strong attention to detail and problem-solving skills. 4. Excellent organizational, documentation, and communication skills. 5. Ability to work independently and in a team environment

Physical Requirements:

1. Manual dexterity 2. Ability to stand for long periods of time. 3. Able to pull and lift up to 50 pounds. 4. Able to spend short periods of time in plasma freezers colder than -40°C.

Job Type:

Full-time Pay:

$27.00 - $35.00 per hour

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Experience:

Quality assurance: 2 years (Preferred) Ability to

Commute:

Miami, FL 33147 (Required) Willingness to travel: 50% (Required)

Work Location:

In person