Job Description

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:

· Life science industry experience.

· Understanding of requirements relating to GMP and GDP. Practical knowledge preferred.

· Experience in investigation techniques and root cause analysis (e.g., Ishikawa and 5-whys).

· Internal and/or external auditing experience conducting thorough audits to ensure compliance with relevant regulations, GxP guidelines, and quality management system.

· Strong technical writing and communication skills.

· Ability to analyze data and processes with a view to making recommendations on areas of improvement.

· High levels of accuracy and attention to detail.

· Authorization to work in the US. This is a US based role.

· Willingness to relocate to Charlotte, North Carolina.

· Fluency in written and spoken English.

Preferred:

· Experience of manufacturing, handling, storage, and distribution of drug products.

· Understanding of, or experience in warehouse processes and operations.

Soft skills:

· Communication : Able to communicate in a clear, appropriate, effective, and efficient manner in various situations (1:1 or group settings, verbal & written).

· Strong Analytical Skills: The ability to collect, organize, visualize, and assimilate data to see patterns, draw conclusions, and find solutions for business.

· Detail-Oriented: Ability to accomplish/complete tasks while demonstrating a thorough concern for all the areas involved, no matter how small.

· Strategic Thinking: Ability to see the big picture, plan ahead, and put thought into action to the advantage of the business.

· Thoroughness: Ensuring that one’s work and information are complete and accurate; following up with others to ensure that agreements and commitments have been fulfilled.

Compensation & Benefits

· Salary commensurate with experience.

· 401k with employer matching.

· Private health insurance.

· Attractive performance incentive plan.

· Vacation, Volunteer, and paid sick leave.

· Hybrid schedule

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

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

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