Pharmaceutical Quality Assurance Specialist

2 weeks ago

Leesburg, Virginia, United States Strive Pharmacy Full time
Job OverviewCompany Background

At Strive Pharmacy, we recognized the limitations of traditional pharmaceuticals and aimed to revolutionize the industry. Our focus on compounding allows us to provide tailored medical solutions that cater to individual patient needs, ensuring better outcomes without the adverse effects commonly associated with standard medications.

Our commitment is to enhance the experience for both our customers and partner clinics. We invite you to experience the Strive difference.

Our Vision

Transforming healthcare through personalized medicine. We are dedicated to challenging the conventional healthcare model that often overlooks the importance of personalized care. Our goal is to foster a proactive approach to health, emphasizing the human connection in every interaction, whether with patients, healthcare providers, or medical practices. We are not just a compounding pharmacy; we are on a mission to innovate healthcare as we know it.

Role Summary

The Quality Assurance Pharmacist will be responsible for ensuring compliance with site-specific quality standards in accordance with Strive Pharmacy's Standard Operating Procedures (SOPs). This includes conducting quality reviews of documentation, overseeing label control, and assisting with product inspections and release activities.

Key Responsibilities
  • Conduct thorough inspections of products to identify defects, leaks, and particulates.
  • Perform environmental monitoring of personnel as required and maintain accurate documentation.
  • Assist in validating media fill processes, including the inspection of filled units.
  • Review documentation related to compounding activities, ensuring accuracy in cleaning records, line clearance forms, and inventory sheets:
    • Confirm that raw materials meet established specifications.
    • Verify labeling accuracy.
    • Review temperature and BMS alarm data.
    • Ensure product test results comply with specification limits.
    • Confirm completeness of all documentation.
    • Document any non-compliance issues and collaborate with supervisors for further investigation as necessary.
  • Support the equipment calibration program and maintain maintenance records.
  • Assist with the release and movement of raw materials.
  • Under supervision, document and initiate quality events related to deviations and non-compliance investigations.
  • Facilitate internal and external audits.
  • Maintain comprehensive quality records, including calibration and maintenance logs, training records, deviation investigations, environmental monitoring, and clean room certifications.
  • Participate in meetings with the Quality Manager's staff.
Required Qualifications
  • Bachelor of Science (BS) in Pharmacy or Doctor of Pharmacy (PharmD) degree.
  • Active Virginia Pharmacist license.
Preferred Skills
  • Experience in pharmaceutical compounding.
  • Understanding of aseptic techniques.
  • Familiarity with USP guidelines (USP 795, 797, 800, and other relevant chapters).
  • Ability to lead and mentor pharmacy staff effectively.
  • Capability to thrive in a dynamic and fast-paced environment.
  • In-depth knowledge of state and federal pharmacy laws and regulations.
Benefits and Perks

Strive Pharmacy offers a comprehensive benefits package, including employer-paid healthcare coverage after 30 days of employment, options for FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and weekends and holidays off. Additionally, employees and their immediate family members receive FREE COMPOUNDED MEDICATIONS.

Work Culture

At Strive, we prioritize a positive workplace culture. Beyond our extensive benefits, we foster a sense of community through various events, including holiday potlucks and celebrations. We are committed to the personal and professional growth of our employees, encouraging them to excel in all areas of their lives.

Diversity and Inclusion

Strive Pharmacy is an equal opportunity employer, dedicated to promoting diversity and inclusion in the workplace. We strictly prohibit discrimination and harassment based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as defined by applicable laws.

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