Quality Assurance Manager

Empower Pharmacy is a dynamic and fast-growing FDA registered 503A Compounding Pharmacy and 503B Outsourcing Facility based in Houston, Texas. Empower takes pride in delivering a broad list of quality healthcare products at competitive prices by disrupting the outdated pharmaceutical model. We believe in providing world class customer service to our patients, while ensuring their safety through investment in people and technology. 

Our leadership understands the basis of Empower’s success is our people. Our diverse, innovative culture is the foundation for the company’s broader perspective. Empower is in search of bright, self-motivated professionals who are focused, open-minded, and hard-working. This is your opportunity to be part of a former start-up company and a culture that will appreciate and leverage your unique talents to make a difference in the lives of our patients.

Responsibilities

  • Review/Perform the Daily Compliance Verification. Document results, and report results to the Director of Manufacturing
  • Perform and/or coordinate completion of: 
  • Environmental monitoring and documentation e.g. personal monitoring, air bioburden, surface bioburden, temperatures, and particle counts
  • Collect environmental monitoring samples as necessary
  • Train new Quality Assurance staff
  • Record sterility testing results, aseptic technique qualifications, and media fill process validations
  • Prepare/revise operating procedures and specifications
  • Review/approve routine change control requests as designated
  • Verify that raw materials meet specifications limits 
  • Oversee control of product labeling/label accountability 
  • Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments
  • Using incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues
  • Lead root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations and CAPA
  • Direct the investigation of excursions in manufacturing or other related operations. Resolve the cause, impact on product quality, disposition and corrective actions 
  • Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batch
  • Verify that product test results meet specification limits
  • Track vendor equipment calibration and maintenance records and assess for deviations 
  • Enter test results or summaries into the monthly and quarterly Quality Assurance report template 
  • Document results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions
  • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification)

Knowledge & Skills

  • Working knowledge of pharmaceutical regulations (USP <797>, cGMP)
  • In-depth knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211), and ICH regulations
  • Effective communication skills, both written and verbal
  • Leadership skills and the ability to facilitate the work activities of others 
  • Ability to act effectively as a member of a team to resolve problems
  • Good organizational and time management skills

Qualifications

  • BS degree in technical or scientific discipline preferably Microbiology and 10 years in pharmaceutical or medical device FDA GMP environment with 5+ years of supervisory experience
  • Ability to work autonomously within established procedures and practices 
  • Experience with international regulatory agencies highly desirable. Thorough knowledge of pharmaceutical manufacturing/controls and Good Manufacturing Practices.
  • Preferred ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional

Benefits

  • Health/Dental/Vision
  • Flexible Spending Account (FSA)
  • Prescription Services
  • 401(k) with company matching
  • Paid Time Off (PTO)
  • Paid Holidays
  • Potential for career growth within an expanding team and organization 

Position Type: Full time

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