QA Specialist II - EVLP
United Therapeutics Corporation
August 22, 2026
Remote friendly (Jacksonville, FL)
United States
Operations
Responsibilities:
- Review documentation for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and applicable GMP, QSR, and clinical trial requirements.
- Perform raw material review and inspection; support material release decisions.
- Coordinate controlled document collaboration, review, and approval for compliant document lifecycle management.
- Provide real-time review of clinical case data (occasional 24/7 availability for remote procedure/data review).
- Conduct QA activities to ensure compliance with regulatory standards (deviation/failure investigations, change control documentation management, complaint handling, SOPs, product quality reviews).
- Review, author, and update SOPs and reports.
- Assist Operations, Quality, and R&D with validation protocol/report preparation and coordinate validation tasks.
- Support FDA and other regulatory inspections by transferring data/documents information timely and accurately.
- Maintain quality files (electronic and physical), including training records, protocols/reports, environmental monitoring, cleaning, and decontamination records.
Qualifications (Minimum Requirements):
- Bachelor’s degree in a related field.
- 3+ years in biotech/pharma/medical device/biologics or other regulated industry.
- 3+ years in Quality Assurance in a GMP/GTP/QSR environment.
- Applied knowledge of GMP/QSR, FDA guidelines, and industry standards (including applying GMP to company processes/products).
- Experience reviewing/auditing quality records; ability to interpret data vs. GMP/GLP/GCP/QSR requirements.
- Excellent professional documentation skills; ability to write clearly about complex issues; ability to produce large volumes of written materials.
- Exceptional problem/risk analysis; ability to interact across departments; ability to review others’ work and enforce policies/procedures; ability to handle confidential information.
Job Location/Work Schedule:
- Jacksonville, FL (hybrid; at least 4 days/week in office, possibly 5).
- On-call: available 24/7 during a one-month team on-call schedule 2–3 times/year.
- Review documentation for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and applicable GMP, QSR, and clinical trial requirements.
- Perform raw material review and inspection; support material release decisions.
- Coordinate controlled document collaboration, review, and approval for compliant document lifecycle management.
- Provide real-time review of clinical case data (occasional 24/7 availability for remote procedure/data review).
- Conduct QA activities to ensure compliance with regulatory standards (deviation/failure investigations, change control documentation management, complaint handling, SOPs, product quality reviews).
- Review, author, and update SOPs and reports.
- Assist Operations, Quality, and R&D with validation protocol/report preparation and coordinate validation tasks.
- Support FDA and other regulatory inspections by transferring data/documents information timely and accurately.
- Maintain quality files (electronic and physical), including training records, protocols/reports, environmental monitoring, cleaning, and decontamination records.
Qualifications (Minimum Requirements):
- Bachelor’s degree in a related field.
- 3+ years in biotech/pharma/medical device/biologics or other regulated industry.
- 3+ years in Quality Assurance in a GMP/GTP/QSR environment.
- Applied knowledge of GMP/QSR, FDA guidelines, and industry standards (including applying GMP to company processes/products).
- Experience reviewing/auditing quality records; ability to interpret data vs. GMP/GLP/GCP/QSR requirements.
- Excellent professional documentation skills; ability to write clearly about complex issues; ability to produce large volumes of written materials.
- Exceptional problem/risk analysis; ability to interact across departments; ability to review others’ work and enforce policies/procedures; ability to handle confidential information.
Job Location/Work Schedule:
- Jacksonville, FL (hybrid; at least 4 days/week in office, possibly 5).
- On-call: available 24/7 during a one-month team on-call schedule 2–3 times/year.