What are the responsibilities and job description for the Quality Assurance Specialist position at Tanner Pharma Group?
Quality Assurance Specialist
Company & Role Description
Founded in 2002, Tanner Pharma Group, TPG, is a specialty service provider in the biopharmaceutical industry focused on improving patient access to medicines on a global basis. Tanner Pharma offers its biopharmaceutical partners a portfolio of four distinct service offerings that span the product lifecycle from clinical development to commercialization. With its global headquarters in Charlotte, North Carolina and offices in the United Kingdom, Switzerland and Brazil, Tanner Pharma is in a phase of rapid growth.
The Quality Assurance Specialist role is responsible for supporting the Tanner Pharma Group, Quality Assurance team in the US. The QA Specialist will work with the QA Manager to drive a culture of Quality and Compliance within TPG. Success in this role requires exceptional communication skills, analytical ability, and strong writing capabilities to ensure high levels of compliance to GDP.
Role Accountabilities
Expected Responsibilities for the Quality Assurance Specialist are :
- Guide the Global Quality Team to ensure compliance with wholesale distribution regulations, current GxP Guidelines, Local Guidelines, and legal requirements. Stay updated on regulatory changes and implement necessary adjustments.
- Ensure all State licenses are current and manage renewal activities.
- Ensure that all relevant customer complaints are addressed efficiently and effectively by conducting in-depth investigations into complaints and deviations and implementing 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 by ensuring credentials are established and maintained for all relevant suppliers and customers in advance of product receipt or supply.
- Contact drug manufacturers, wholesalers, and clients when required to resolve issues.
- Lead and oversee self-inspections according to the written audit schedule. Assist in external audits as needed.
- Assist the Quality Manager in keeping up to date and carrying out annual SOP / Documentation reviews.
- Support other operational functions in the creation and drafting of operational SOPs that impact GxP operations.
- Develop and facilitate internal training initiatives to include core QMS activities.
- Drive implementation of Quality Assurance initiatives.
- Identify and lead process improvement initiatives to enhance efficiency and effectiveness.
- Liaise with service providers to maintain contractual agreements for maintenance and calibration activities for critical equipment.
- Assist in drafting and completing change controls.
- Lead the recall process, including coordination and execution or product recalls and mock recalls.
- Generate and analyze reports on QA key performance indicators to be presented to Senior Management.
Desired Candidate Profile & Capabilities
Required :
Preferred :
Soft skills :
Compensation & Benefits
Tanner Pharma Group’s Core Values : Everything we do at Tanner Pharma Group is dictated by our values. We take them very seriously, and we are proud of this unwavering commitment.
Check out to view our core values and learn more about our company.
Candidates may be required to organize reference calls upon request. Confidentiality will be respected. Additionally, Pre-employment drug and background screening will be required.
Tanner Pharma Group is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
Job Type : Full-time
Salary : $50,000 - $60,000
