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Quality Assurance Associate

Full Job Description

Quality Assurance Associate

Company 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. Each of its service offerings has a component of the distribution of pharmaceutical and related products according to Good Distribution Practices (GDP), and most recently, the company has set up a labeling and packaging operation that operates according to Good Manufacturing Practices (GMP). Tanner Pharma operates a globally harmonized Quality Management System (QMS) and has distribution licenses across the US, UK (MHRA) and Switzerland (Swissmedic), but the business operates across more than 120 countries. The company is currently in a phase of rapid growth and to support this growth, is seeking a QA Associate responsible for supporting the Tanner Pharma Group, Quality Assurance team in the US.

Role Description: Working with and assisting the team to ensure that the Global Quality Management System is maintained according to the current GDP and GMP guidelines. Responsible for networking with internal/external parties to maintain key relationships. Success in this role requires exceptional communication skills, analytical ability, and strong writing capabilities to ensure high levels of compliance to GDP. Expected responsibilities for the QA Associate are:

  • Work with the Quality Team to ensure compliance with the general conditions of relevant wholesale distribution regulations, current GxP Guidelines and Local Guidelines, legal requirements, and updates.
  • Ensure all State licenses are current and take the lead on renewal activities. Conduct in-depth investigations to respond to complaints and deviations, raising CAPAs where appropriate.
  • Communicate quality issues with drug manufacturers, wholesalers and clients and works proactively to deliver acceptable quality solution
  • Participate in audit hosting related activities to ensure we are always audit ready.
  • Facilitate supplier & customer approval by ensuring credentials are established and maintained for all relevant suppliers and customers in advance of product receipt or supply.
  • Be involved in any decisions to quarantine or dispose of returned, rejected, recalled, or counterfeit drugs.
  • Assist in the management of product recalls and carrying out mock recall(s)
  • Support critical QMS activities including document control, change management, risk management.
  • Ensure that all relevant customer complaints are dealt with efficiently and effectively in collaboration with key stakeholders.
  • Ensure self-training and attendance at appropriate workshops/training courses, to keep up to date with regulations.
  • Identify areas where improvements can be made to processes.
  • Perform other duties and projects as assigned.

Qualifications

Required:

  • Life science industry experience
  • Understanding of requirements relating to GDP.
  • High levels of accuracy and attention to detail
  • Ability to effectively and constructively communicate across departmental disciplines while pursuing project goals
  • 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 in manufacturing, handling, storage, and distribution of drug products
  • Understanding of, or experience in warehouse processes and operations.

Compensation & Benefits

  • Salary commensurate with experience
  • Company 401k
  • Private health insurance
  • Attractive performance incentive plan with profit sharing
  • Vacation and paid sick leave

Check out www.tannerpharma.com to learn more about our company.

Candidates may be required to organize reference calls with recent supervisors. You will be expected to pitch to the Interview team at the end of the process- please prepare accordingly. Confidentiality will be respected. Additionally, 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: $35,000.00 – $45,000.00 per year

Schedule:

  • 8 hour shift
  • Monday to Friday

Education:

  • High school or equivalent (Preferred)

Experience:

  • Supply chain/ logistics and product flows: 2 years (Preferred)
  • Warehouse processes and operations: 1 year (Required)
  • Handling, storage, and distribution of drug products: 1 year (Required)
  • Data analytics: 1 year (Preferred)
  • Life science industry: 1 year (Required)

Work Location: One location

Apply Now

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