Position Description
As Quality Control (QC) Analyst, the incumbent is responsible for successfully creating procedures for operation of QC lab instruments, coordinating the analytical test method validations, performing the analytical testing per established procedures, documenting the results, and reports accordingly. The individual will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation. Experience with HPLC/UPLC and working in a GMP laboratory environment is preferred.
Essential Duties and Responsibilities
Key responsibilities will include
- Method Development and Validation (HPLC)
- Creating procedures for operation of various analytical instruments and wet chemistry testing.
- Inspection and release of Raw Materials and Components
- Inspection and release of Finished Products
- Status control of raw materials, packaging materials & finished products
- Sampling of raw materials and components
- Testing of raw materials by Compendial methodology
- Inspection of printed and unprinted packaging materials
- Format of material specifications
- Initiate and own investigations, deviations, CAPAs, and change controls within the electronic Quality Management System.
- Laboratory Control Systems
- Environmental Monitoring
- Qualification and Performance verification of Laboratory Equipment
- Escalate properly to QC/QA Senior Management, and other relevant management functions of potential or real situations that require management addressing.
- As needed, implement and manage Quality Audit systems and guidelines
- Stay abreast of evolving regulatory compliance practices related to GMP and GLP systems.
- Other duties as assigned.
Regularly interacts with other key functions, senior leadership, and external clients.
Qualifications & Experience
- Bachelor’s (Required)
- Quality Control: 2 years (Preferred)
- HPLC/UPLC: 2 years (Preferred)
- Proficiency with Empower (Preferred)
- Proficiency with MS Office Suite (Preferred)
