• Job Description

  Req#: QUALI001452

  What We’re Looking For

  We are seeking a detail-oriented and motivated Quality Assurance (QA) Specialist to join our team in a GMP-regulated environment. The QA Specialist will play a vital role in ensuring that all products meet the highest standards of quality, safety, and regulatory compliance in accordance with Good Manufacturing Practices (GMP). The ideal candidate will have a strong background in quality assurance, a deep understanding of GMP guidelines, and the ability to collaborate effectively with cross-functional teams to ensure that processes and products meet both internal standards and regulatory requirements.

  What You Will Do

  • Collaborate with department management on investigations and develop strategies to prevent future quality deviations.
  • Lead, initiate, track, and trend investigations related to customer product complaints.
  • Verify the accuracy of reported complaints and make corrections before triaging customer product complaints.
  • Provide customer support and resolve inquiries related to product complaints via phone or email.
  • Assist subject matter experts in conducting root cause analysis.
  • Utilize technical writing strategies to ensure investigative reports are clear, concise, and complete.
  • Report potential quality issues that may impact product quality or regulatory compliance to Quality Management.
  • Compile and maintain quality performance metrics, analyzing trends for continuous improvement.
  • Create, update, and review Standard Operating Procedures (SOPs) in compliance with GMP regulations.
  • Assist MasterControl Sysadmins with troubleshooting issues and process improvements.
  • Conduct internal audits to assess compliance with regulatory and quality requirements.
  • Support external audits conducted by regulatory agencies, providing necessary documentation.
  • Ensure all equipment is calibrated on schedule and in compliance with GMP regulations.
  • Review and approve calibration certificates and maintenance records to verify equipment functionality.
  • Perform other duties as assigned.

  Who You Are

  • Bachelor’s degree in a relevant field.
  • Minimum 5 years of experience in investigations, root cause analysis, and CAPA execution in an FDA-regulated environment.
  • Proficiency in root cause analysis tools and investigative methodologies.
  • Strong knowledge of GMP, ICH guidelines, pharmaceutical compendia, and FDA regulations.
  • Excellent critical thinking, analytical reasoning, and problem-solving skills.
  • Strong technical writing skills for SOPs and investigative reports.
  • Strong communication and customer service skills.
  • Experience generating and interpreting quality metrics.
  • Ability to thrive in a fast-paced environment while meeting productivity demands.
  • Effective time management skills to meet deadlines and manage workload.
  • Ability to present issues and trends in clear, technical language.
  • Experience with electronic quality management systems.
  • Experience conducting internal audits and participating in regulatory inspections is a plus.

  Who We Are

  PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patients’ lives. As a complete resource for independent compounding pharmacists, PCCA provides high-quality products, education and support to more than 3,000 pharmacy members throughout the United States, Canada, Australia and other countries around the world. Incorporated in 1981 by a network of pharmacists, PCCA has supported pharmacy compounding for over 40 years. Learn more at www.pccarx.com.

  Qualifications

  Behaviors

  Preferred

  Innovative : Consistently introduces new ideas and demonstrates original thinking

  Detail Oriented : Capable of carrying out a given task with all details necessary to get the task done well

  Equal Opportunity Employer
  This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

• About the company

  PCCA is the leading supplier of pharmacy chemicals, pharmacy equipment, and pharmacy compounding education that empowers compounding pharmacies to make personalized medicine for unique patient health challenges.

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