Quality Assurance Specialist
3 days ago
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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