Quality Assurance Pharmacist

Houston, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Company Overview

At Allia Health the umbrella organization for Southend Pharmacy Brello Health and Woven we dont just follow industry trendswe redefine them. Our mission is to commoditize anti-aging solutions making them affordable and accessible to the average consumernot just the wealthy. By offering customized and cost-effective wellness products that follow cost-containment models we aim to improve peoples quality of life and meet them wherever they are on their health journey.

Job Summary

The Quality Assurance (QA) Pharmacist plays a critical role in ensuring compliance with applicable regulations compounding standards and internal procedures in a 503A compounding pharmacy. This position is responsible for maintaining the integrity of compounded preparations through oversight of quality systems documentation and continuous improvement practices. The QA Pharmacist will work collaboratively with pharmacy staff to ensure patient safety product quality and regulatory compliance.

Key Responsibilities

Develop implement and maintain QA systems in alignment with USP <795> <797> <800> state board of pharmacy regulations and other applicable standards.
Monitor document and investigate reported adverse events or product complaints and ensure timely reporting to appropriate regulatory bodies and implement follow-up actions including root cause analysis trending and corrective measures in accordance with pharmacy policies and applicable laws.
Conduct and/or oversee routine audits of sterile and non-sterile compounding processes facilities equipment and documentation.
Review and approve compounding records batch release documents and standard operating procedures (SOPs).
Investigate deviations non-conformances and out-of-specification results; lead root cause analysis and ensure appropriate corrective and preventive actions (CAPAs).
Oversee and ensure proper handling storage and qualification of raw materials and components.
Conduct risk assessments to evaluate and mitigate potential quality or compliance issues.
Coordinate and respond to quality-related inspections by state or federal agencies.
Maintain records in compliance with documentation requirements.
Support change control validation and qualification efforts related to new processes products or equipment

Qualifications

Education:Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited institution.
Licensure:Active pharmacist license in good standing with the Texas State Board of pharmacy (multistate licensure is a plus).
Experience:Minimum of 1-2 years of experience in sterile compounding preferably in a 503A pharmacy with a strong understanding of USP <797> <795> <800> and cGMP standards.
Skills:In-depth knowledge of sterile compounding techniques aseptic processing and quality assurance principles; Strong analytical and problem-solving skills to investigate deviations and implement effective solutions; Excellent attention to detail and organizational skills to manage complex documentation and compliance requirements; Effective communication and training skills to educate staff and collaborate with cross-functional teams; Proficiency in pharmacy information systems and quality management software; Ability to train and mentor team members on quality systems and compliance.

Preferred

1 year in a quality assurance or compliance-related role preferred.

Physical Requirements

This role requires routine presence in cleanroom and laboratory environments.
May involve standing gowning and working in controlled environments for extended periods.

Benefits

Comprehensive benefits package including medical dental paid time off.

Allia Health Groupis unable to offer visa sponsorship at this time. Candidates must be legally authorized to work in the United States without current or future sponsorship.

Equal Opportunity Employer Statement

Allia Health Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race color religion gender gender identity or expression sexual orientation national origin genetics disability age or veteran status.

If you have any questions or require accommodations during the application process please contact

Company OverviewAt Allia Health the umbrella organization for Southend Pharmacy Brello Health and Woven we dont just follow industry trendswe redefine them. Our mission is to commoditize anti-aging solutions making them affordable and accessible to the average consumernot just the wealthy. By offeri...

Company Overview

Job Summary

Key Responsibilities

Develop implement and maintain QA systems in alignment with USP <795> <797> <800> state board of pharmacy regulations and other applicable standards.
Monitor document and investigate reported adverse events or product complaints and ensure timely reporting to appropriate regulatory bodies and implement follow-up actions including root cause analysis trending and corrective measures in accordance with pharmacy policies and applicable laws.
Conduct and/or oversee routine audits of sterile and non-sterile compounding processes facilities equipment and documentation.
Review and approve compounding records batch release documents and standard operating procedures (SOPs).
Investigate deviations non-conformances and out-of-specification results; lead root cause analysis and ensure appropriate corrective and preventive actions (CAPAs).
Oversee and ensure proper handling storage and qualification of raw materials and components.
Conduct risk assessments to evaluate and mitigate potential quality or compliance issues.
Coordinate and respond to quality-related inspections by state or federal agencies.
Maintain records in compliance with documentation requirements.
Support change control validation and qualification efforts related to new processes products or equipment

Qualifications

Education:Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited institution.
Licensure:Active pharmacist license in good standing with the Texas State Board of pharmacy (multistate licensure is a plus).
Experience:Minimum of 1-2 years of experience in sterile compounding preferably in a 503A pharmacy with a strong understanding of USP <797> <795> <800> and cGMP standards.
Skills:In-depth knowledge of sterile compounding techniques aseptic processing and quality assurance principles; Strong analytical and problem-solving skills to investigate deviations and implement effective solutions; Excellent attention to detail and organizational skills to manage complex documentation and compliance requirements; Effective communication and training skills to educate staff and collaborate with cross-functional teams; Proficiency in pharmacy information systems and quality management software; Ability to train and mentor team members on quality systems and compliance.

Preferred

1 year in a quality assurance or compliance-related role preferred.

Physical Requirements

This role requires routine presence in cleanroom and laboratory environments.
May involve standing gowning and working in controlled environments for extended periods.

Benefits

Comprehensive benefits package including medical dental paid time off.

Allia Health Groupis unable to offer visa sponsorship at this time. Candidates must be legally authorized to work in the United States without current or future sponsorship.

Equal Opportunity Employer Statement

If you have any questions or require accommodations during the application process please contact