Quality Assurance Specialist
Full-TimeJob Overview
Job Title: Quality Assurance Specialist
Location: Houston, Texas (Onsite)
Reports To: Quality Assurance Manager
About Revive RX:
Revive RX is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We focus on addressing the root cause of health concerns, not just the symptoms, through personalized care powered by advanced technology. Our collaborative model brings together pharmacists, healthcare providers, and pharmaceutical manufacturers to deliver superior outcomes. Our mission is to optimize treatments, transform healthcare, and empower individuals to live healthier, more fulfilling lives. We invite you to join our team and contribute to our vision of personalized, holistic healthcare.
Position Summary:
The Quality Assurance (QA) Specialist plays a critical role in maintaining the integrity of quality systems and ensuring compliance with internal procedures, USP <797>/<800>, and applicable regulatory standards. This position supports a wide range of QA functions including documentation review, deviation investigations, CAPA management, change control, audit readiness, and training coordination. While the primary focus is on quality system oversight, the role will also support vendor and material qualification activities as needed.
Key Responsibilities:
Quality Systems & Compliance Oversight:
- Participate in the management and continuous improvement of quality systems including deviation handling, CAPA, change control, and document management.
- Review executed batch records and associated documentation for completeness and compliance prior to final disposition.
- Assist in the preparation and execution of internal audits and regulatory inspections, including document retrieval and response development.
- Author, revise, and review Standard Operating Procedures (SOPs), policies, and quality documentation to reflect current practices and regulations.
Deviation, CAPA & Change Control:
- Conduct and support root cause investigations for deviations, non-conformances, and complaints.
- Develop and monitor CAPA plans to ensure timely and effective resolution of quality issues.
- Review and approve change control requests to ensure proper impact assessment and implementation.
Training & Cross-functional Support:
- Support and deliver QA-related training to ensure staff awareness and compliance with quality practices.
- Collaborate with operations, compounding, QC, and supply chain teams to resolve quality concerns in real time.
- Provide QA input on new processes, equipment, or materials being introduced into production.
Required Qualifications:
- Minimum 3 years of experience in Quality Assurance within a regulated pharmaceutical, biotech, or compounding environment.
- Familiarity with quality systems such as deviation management, CAPA, and document control.
- Strong attention to detail, communication, and analytical skills.
- Ability to adapt in a dynamic, fast-paced setting and manage multiple priorities.
Preferred Qualifications:
- Bachelor’s degree in Life Sciences, Chemistry, or a related field.
- Experience with sterile or non-sterile compounding processes.
- Familiarity with eQMS, ERP, or inventory systems.
- Exposure to vendor qualification or materials management processes.
Disclaimer:
The responsibilities outlined above are intended to describe the general nature and level of work being performed. Duties and responsibilities may change based on business needs and leadership direction. This description does not constitute a contract or guarantee of employment.
Job Title: Quality Assurance Specialist
Location: Houston, Texas (Onsite)
Reports To: Quality Assurance Manager
About Revive RX:
Revive RX is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We focus on addressing the root cause of health concerns, not just the symptoms, through personalized care powered by advanced technology. Our collaborative model brings together pharmacists, healthcare providers, and pharmaceutical manufacturers to deliver superior outcomes. Our mission is to optimize treatments, transform healthcare, and empower individuals to live healthier, more fulfilling lives. We invite you to join our team and contribute to our vision of personalized, holistic healthcare.
Position Summary:
The Quality Assurance (QA) Specialist plays a critical role in maintaining the integrity of quality systems and ensuring compliance with internal procedures, USP <797>/<800>, and applicable regulatory standards. This position supports a wide range of QA functions including documentation review, deviation investigations, CAPA management, change control, audit readiness, and training coordination. While the primary focus is on quality system oversight, the role will also support vendor and material qualification activities as needed.
Key Responsibilities:
Quality Systems & Compliance Oversight:
- Participate in the management and continuous improvement of quality systems including deviation handling, CAPA, change control, and document management.
- Review executed batch records and associated documentation for completeness and compliance prior to final disposition.
- Assist in the preparation and execution of internal audits and regulatory inspections, including document retrieval and response development.
- Author, revise, and review Standard Operating Procedures (SOPs), policies, and quality documentation to reflect current practices and regulations.
Deviation, CAPA & Change Control:
- Conduct and support root cause investigations for deviations, non-conformances, and complaints.
- Develop and monitor CAPA plans to ensure timely and effective resolution of quality issues.
- Review and approve change control requests to ensure proper impact assessment and implementation.
Training & Cross-functional Support:
- Support and deliver QA-related training to ensure staff awareness and compliance with quality practices.
- Collaborate with operations, compounding, QC, and supply chain teams to resolve quality concerns in real time.
- Provide QA input on new processes, equipment, or materials being introduced into production.
Required Qualifications:
- Minimum 3 years of experience in Quality Assurance within a regulated pharmaceutical, biotech, or compounding environment.
- Familiarity with quality systems such as deviation management, CAPA, and document control.
- Strong attention to detail, communication, and analytical skills.
- Ability to adapt in a dynamic, fast-paced setting and manage multiple priorities.
Preferred Qualifications:
- Bachelor’s degree in Life Sciences, Chemistry, or a related field.
- Experience with sterile or non-sterile compounding processes.
- Familiarity with eQMS, ERP, or inventory systems.
- Exposure to vendor qualification or materials management processes.
Disclaimer:
The responsibilities outlined above are intended to describe the general nature and level of work being performed. Duties and responsibilities may change based on business needs and leadership direction. This description does not constitute a contract or guarantee of employment.