Quality Analyst
Quality Analyst
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This position supports quality activities within Commercial Quality including compliance with controlled substance regulations complaint handling change control documentation and audit coordination. The role requires adherence to environmental policies and contribution to departmental environmental objectives.
Responsibilities:
- Customer Applications (50%): Process Know Your Customer (KYC) applications for SPRAVATO purchases.
- Data Analysis (10%): Conduct routine data analysis for Suspicious Order Monitoring.
- Product Quality Complaints (10%): Handle PQCs in the quality system including evaluations investigations summaries and workflow management.
- Quality Events & Change Control (10%): Manage records in Track Wise/COMET.
- Documentation (10%): Coordinate documents/procedures in true Vault or equivalent systems.
- Audits (10%): Coordinate internal/supplier audits-logistics planning execution CAPA coordination and documentation in Track Wise.
- Support enterprise-wide and global business quality and compliance initiatives.
- BA/BS in Technical or Life Sciences.
- MA/MS/MBA in Business Technical or Life Sciences.
- 5 years in the pharmaceutical or related industry.
- Strong knowledge of GMP/GDP and DEA regulations.
- Experience within quality organizations.
- Familiarity with regulatory inspection expectations.
- Proficiency in Track Wise/COMET data reporting and Excel.
- Strong leadership with a results-oriented mindset.
- Ability to collaborate across departments like IT Manufacturing Regulatory and Commercial.
- Experience in managing audits documentation and quality events.
- Credo Values.
- Innovation.
- Mastering Complexity.
- Customer/Marketplace Focus.
- Independent Partnering.
Employment Type
Full-time
