Quality Assurance Specialist
4 weeks ago
At Tanner Pharma Group, we are seeking a highly skilled Quality Assurance Specialist to join our team in Charlotte, North Carolina. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest levels of compliance with regulatory requirements and industry standards.
Key Responsibilities:- Guide the Global Quality Team to ensure compliance with wholesale distribution regulations, current GxP Guidelines, Local Guidelines, and legal requirements.
- Ensure all State licenses are current and manage 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.
- Contact drug manufacturers, wholesalers, and clients to resolve issues.
- Lead and oversee self-inspections and external audits.
- Assist in keeping up to date and carrying out annual SOP/Documentation reviews.
- Support operational functions in creating and drafting 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.
- Life science industry experience.
- Understanding of requirements relating to GMP and GDP.
- Experience in investigation techniques and root cause analysis.
- Internal and/or external auditing experience.
- 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.
- Willingness to relocate to Charlotte, North Carolina.
- Fluency in written and spoken English.
- Experience of manufacturing, handling, storage, and distribution of drug products.
- Understanding of, or experience in warehouse processes and operations.
- Salary commensurate with experience.
- 401k with employer matching.
- Private health insurance.
- Attractive performance incentive plan.
- Vacation, Volunteer, and paid sick leave.
- Hybrid schedule.
We take our core values very seriously and are proud of this unwavering commitment. Check out our core values to 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, $60,000.00 per year
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