Quality Control Specialist

2 weeks ago

Irving, Texas, United States Carie Boyd Pharmaceuticals Full time
Job Overview

Quality Control Specialist – Review & Disposition

About Our Company:

Carie Boyd Pharmaceuticals is a nationally recognized 503B FDA outsourcing registered facility, dedicated to fulfilling the needs of our patients and healthcare providers through a diverse range of office-use products, including injectables, pellets, and topical formulations. Being part of the Carie Boyd team signifies a commitment to patient care, quality assurance, and the ambition to expand our innovative business in various directions.

Position Summary:

The successful candidate will collaborate effectively with colleagues to ensure excellence in both written and verbal communications, as well as in planning, documenting, organizing, and executing multiple tasks in a fast-paced environment. Additional quality-related responsibilities may be assigned as necessary.

Key Responsibilities:

  • Conduct batch record evaluations and disposition for assigned product categories.
  • Perform Finished Product AQL assessments.
  • Update the status of finished products.
  • Review and authorize quality events as designated.
  • Draft Quality Event Reports as required.
  • Prepare Annual Quality Reports (AQR) as needed.
  • Execute Quality Reviews of AQR and Annual Product Reviews (APR).
  • Participate in meetings to coordinate and discuss disposition timelines.
  • Document actions in accordance with good documentation practices.
  • Support the Quality Department during regulatory inspections.

Document Control and Label Management Responsibilities:

  • Digitally archive batch records, forms, and quality events.
  • Execute Document Control tasks.
  • Organize documents in the designated SharePoint locations.
  • Oversee Change Management processes.
  • Circulate documents for approval within Change Management Systems.
  • Log and monitor Change Management documentation.
  • Modify controlled documents as necessary.
  • Document actions in compliance with good documentation practices.
  • Manage Label Control tasks, including printing labels and batch records, and assisting with label reconciliation.
  • Prepare materials for shipment for testing purposes.
  • Perform additional duties as assigned.

Qualifications:

· Bachelor's Degree or higher in a life science or related field, or 5 years of GMP experience.

· Minimum of 3 years in a quality assurance role.

· Preferred experience in review & disposition or direct involvement in a sterile environment.

· Exceptional attention to detail.

· Familiarity with FDA and USP guidelines.

· Strong oral and written communication abilities.

· Dependability, professionalism, and the ability to convey assurance and confidence.

· Team-oriented with a focus on customer service.

· Proficient in Windows-based applications, with a willingness to learn new software.

Confidentiality Statement:

Employees are required to maintain the confidentiality of company information and, in accordance with State and Federal Law (including the Health Insurance Portability and Accountability Act of 1996), protected health information.

Equal Opportunity Employer:

Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, we will provide reasonable accommodations to qualified individuals with disabilities and encourage both prospective and current employees to discuss potential accommodations with the employer.

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