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Quality Control Unit Lead-503b outsourcing facility

PGRrx LLC
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Job Overview

PGRrx is a 503B outsourcing facility dedicated to providing high-quality compounded sterile and non-sterile preparations to healthcare providers and facilities. Our commitment to safety, quality, and regulatory compliance ensures that we meet the needs of our patients and partners.

The Quality Control Unit (QCU) Lead is responsible for managing and overseeing all quality control (QC) activities at a 503B outsourcing facility to ensure compliance with FDA regulatory requirements, including Current Good Manufacturing Practices (cGMP) and USP standards. The QCU Lead plays a critical role in maintaining the quality and safety of compounded sterile preparations (CSPs) by managing QC testing, environmental monitoring, and ensuring the integrity of all raw materials, in-process products, and finished goods.

Responsibilities

Regulatory Compliance:

  • Ensure QC activities comply with FDA 503B outsourcing facility requirements, cGMP standards, applicable USP standards referenced by the FDA
  • Develop, review, and approve QC-related Standard Operating Procedures (SOPs) to ensure compliance with regulatory standards.
  • Act as a key contributor during internal and external audits, including FDA inspections.
  • Stay up to date on regulatory changes and implement updates to QC processes as needed.

Quality Control Testing:

  • Oversee all QC testing activities, including sterility, endotoxin, potency, particulate matter, and pH testing, to ensure compliance with product specifications.
  • Develop, validate, and implement testing methods and protocols for raw materials, in-process samples, and finished products.
  • Monitor and assess environmental monitoring (EM) data to ensure compliance with cleanroom standards.
  • Conduct investigations and review out-of-specification (OOS) results, ensuring root cause analysis and corrective/preventive actions (CAPAs) are effectively implemented.

Documentation and Record Keeping:

  • Ensure accurate and thorough documentation of all QC activities in compliance with regulatory requirements and data integrity principles (ALCOA+).
  • Review and approve test results, Certificates of Analysis (COAs), and QC reports.
  • Maintain comprehensive records of raw material testing, finished product testing, and stability studies.

Equipment and Laboratory Oversight:

  • Oversee the maintenance, calibration, and qualification of all QC laboratory equipment to ensure accuracy and reliability.
  • Ensure proper inventory and management of laboratory supplies and reagents.
  • Work closely with external laboratories to coordinate outsourced testing when required.

Team Leadership and Training:

  • Supervise and manage QC personnel, providing leadership, guidance, and mentorship.
  • Develop and implement training programs for QC staff to ensure competency in testing procedures, cGMP requirements, and regulatory standards.
  • Conduct performance reviews and support career development for team members.

Collaboration and Communication:

  • Work closely with the Quality Assurance (QA) team to address deviations, OOS results, and CAPAs.
  • Collaborate with production, R&D, and supply chain teams to ensure seamless integration of QC activities with overall manufacturing processes.
  • Serve as a key point of contact for customers and regulatory agencies regarding QC-related inquiries and audits.

Continuous Improvement:

  • Identify and implement opportunities for process improvements to enhance the efficiency, accuracy, and compliance of QC operations.
  • Analyze quality metrics and trends to identify potential risks and areas for improvement.
  • Lead initiatives to ensure the QC unit aligns with best practices in the pharmaceutical industry.

Education and Licensure

  • Bachelor’s degree in Chemistry, Microbiology, Pharmacy, or a related scientific discipline.
  • Advanced degree (e.g., Master’s or Ph.D.) preferred.
  • Additional certifications in quality or regulatory fields (e.g., CQE, CQA) are a plus.

Experience

  • Experience in a QC role within a pharmaceutical manufacturing or 503B outsourcing facility.
  • Proven experience with sterility testing, endotoxin testing, and other QC methodologies.
  • In-depth understanding of FDA 503B regulations, cGMP standards, USP requirements, and cleanroom operations.
  • Leadership experience, including managing a QC team, preferred.

Contact Information

Interested applicants should email their resume to info@pgrrx.com