Quality Assurance Manager
Empower Pharmacy
Houston, TX Posted 1/2/2021 Full Time Professional, Manufacturing, Healthcare, Management

Position Summary

The Quality Assurance Manager oversees and manages the quality assurance process to adhere to guideline established by regulating agencies and boards to ensure compliance to regulations in the delivery of a quality product. 

Duties and Responsibilities

  • Reviews/performs Daily Compliance Verification 
  • Documents and reports results to the Director of Manufacturing 
  • Environmental monitoring and documentation of personal monitoring, air bioburden, surface bioburden, temperatures, and particle counts 
  • Collects environmental monitoring samples as necessary 
  • Trains new Quality Assurance staff 
  • Records sterility testing results, aseptic technique qualifications, and media fill process validations 
  • Prepares/revises operating procedures and specifications 
  • Reviews/approves routine change control requests as designated 
  • Verifies that raw materials meet specifications 
  • Oversees control of product labeling/label accountability  
  • Recommends and/or implements improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments 
  • Uses incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and responds to process and service issues 
  • Leads root cause analysis and CAPA for audit observations, product complaints, product non-conformances, and in-process deviations 
  • Directs the investigation of excursions in manufacturing or other related operations 
  • Performs final review of test data/reports to ensure conformance to the established specifications and standard operating procedures 
  • Verifies that product test results meet specifications 
  • Tracks vendor equipment calibration and maintenance records and assess for deviations  
  • Enters test results or summaries into the monthly and quarterly Quality Assurance report template  
  • Documents results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions 
  • Maintains quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification) 

Knowledge and Skills

  • In-depth knowledge of USP , cGMP, 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  
  • Proficiency with computer software, SharePoint preferred 
  • Ability to act effectively as a member of a team to resolve problems 
  • Good organizational and time management skills 
  • Ability to work autonomously within established procedures and practices  

Experience and Qualifications

  • Bachelor of Science in technical or scientific discipline preferably Microbiology and 10 years in pharmaceutical or medical device FDA GMP environment with 5+ years of supervisory experience 
  • Experience with international regulatory agencies highly desirable 
  • Thorough knowledge of pharmaceutical manufacturing/controls 
  • 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) or Health Savings Accounts (HSA)  
  • 401(k) with company matching  
  • Paid Vacation (10 days) 
  • Paid Holidays (8 days) 
LOCATION:
5980 W Sam Houston Pkwy N
Houston, TX 77041
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