Quality Assurance Specialist

3 days ago


Charlotte, North Carolina, United States Tanner Pharma Group Full time
Job Title: Quality Assurance Specialist

Company Overview:

Tanner Pharma Group is a specialty service provider in the biopharmaceutical industry focused on improving patient access to medicines globally.

Job Summary:

We are seeking a Quality Assurance Specialist to support our Quality Assurance team in the US. The successful candidate will work closely with the QA Manager to drive a culture of Quality and Compliance within TPG.

Key Responsibilities:

  • Ensure compliance with wholesale distribution regulations, current GxP Guidelines, Local Guidelines, and legal requirements.
  • Manage State licenses and renewal activities.
  • Investigate customer complaints and deviations, and implement CAPAs as necessary.
  • Review and approve equipment and service logs.
  • Make disposition decisions regarding quarantined and returned product.
  • Oversee the approval process of supplier and customer credentials.
  • Lead and oversee self-inspections and external audits.
  • Assist in SOP/Documentation reviews and create operational SOPs.
  • Develop and facilitate internal training initiatives.
  • Drive implementation of Quality Assurance initiatives and process improvements.

Requirements:

  • Life science industry experience.
  • Understanding of GMP and GDP requirements.
  • Investigation techniques and root cause analysis experience.
  • Internal and/or external auditing experience.
  • Strong technical writing and communication skills.
  • Ability to analyze data and processes.
  • High levels of accuracy and attention to detail.

Preferred Qualifications:

  • Experience in manufacturing, handling, storage, and distribution of drug products.
  • Understanding of warehouse processes and operations.

What We Offer:

  • Salary commensurate with experience.
  • 401k with employer matching.
  • Private health insurance.
  • Attractive performance incentive plan.
  • Vacation, Volunteer, and paid sick leave.

Tanner Pharma Group's Core Values:

We take our values seriously and are proud of our commitment to excellence.

Learn more about our company.

Tanner Pharma Group is an Equal Opportunity/Affirmative Action employer.

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year



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