Quality Control Manager
Company: Empower Pharmacy
Location: Houston , TX
Category: Healthcare, Professional
Job Type: Full Time
Posted: 7/7/2020
Company Overview
Empower Pharmacy is a dynamic and fast growing FDA registered 503A Compounding Pharmacy and 503B Outsourcing Facility based in Houston, Texas. We are focused on delivering the finest quality healthcare products at competitive prices by offering efficient solutions that disrupt antiquated pharmaceutical models. We believe in providing world class customer service to our patients, while ensuring their safety through investment in our people and the latest technologies.
Our leadership understands that the basis of our company’s success is our people. Our diverse culture is akin to a fast-paced Silicon Valley startup and is the foundation for the company’s broader perspective to serve the needs of our patients through innovation. 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 company and culture that will appreciate and leverage your unique talents to make a difference in the lives of our patients.

Job Summary
The Quality Control Manager oversees and manages the visual inspection and labeling departments to ensure quality and consistency is maintained.

Duties and Responsibilities
  • Plans, organizes, and evaluates activities for direct reports within the Visual Inspection and Labeling departments
  • Manages daily performance of multi-shift team to ascertain output. Coach personnel and manage headcount respectively
  • Responsible for the inspection of finished sterile and non-sterile preparations to identify any abnormalities, foreign particles, or defects
  • Responsible for the labeling of finished sterile and non-sterile dosage forms
  • Assists with the inspection and labeling of preparations as needed
  • Responsible for comprehensive quality rejects. 
  • Identifies and segregates defective units according to defect type; and notify appropriate party of defective product requiring corrective action 
  • Develops processes and SOPs
  • Trains team on processes and SOPs
  • Manages Work-In-Progress (WIP) stock and release of stock to Operations
  • Follows procedures regarding safety and quality, and ensure the cleanliness of the departments
  • Comprehensive knowledge of cGMP and other applicable regulatory requirements with demonstrated success in application
  • Demonstrates a serious commitment to accuracy and quality while meeting department goals, quotas, and deadlines
  • Completes other projects and duties as required and assigned within an allotted time
Knowledge and Skills
  • Possess excellent organizational skills and attention to detail
  • Ability to function in an atmosphere of constant change with detailed accuracy
  • Ability to establish, maintain, and supervise working relationships cross functionally
  • Ability to communicate effectively, both verbally and in writing, to all levels within the organization
  • Working knowledge of pharmaceutical regulations (USP <797>, cGMP)
  • In-depth knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211), and ICH regulations
  • Leadership skills and the ability to facilitate the work activities of others 
  • Proficiency with computer software, Micorsoft SharePointe preferred
  • Health/Dental/Vision 
  • Flexible Spending Account (FSA) or Health Savings Accounts (HSA) 
  • 401(k) with company matching, no vesting period 
  • Paid holidays  (8 days) 
  • Paid Vacation  (10 days) 
  • Opportunity for growth in a fast-paced growing company 

Position Type
  • Full time
  • Salaried

Experience and Qualifications

  • Bachelor degree in technical or scientific discipline preferably Microbiology, Chemistry or Pharmacy
  • 5+ years related experience in pharmaceutical or medical device FDA GMP environment with supervisory experience
  • 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
  • Must be able to pass pre-employment visual qualifications: 20/20 vision with or without corrective lenses, and ability to see all colors
  • Ability to visually discern product specifications across multiple products
  • Ability to read, understand, follow and comply with technical and written documents
  • Follow detailed processing instructions as well as clearly and accurately document all necessary documentation
  • Advanced computer skills required – Microsoft Office Heavy User (SharePoint, Forms, Excel)

Houston, TX 77079
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