Job description:
Position Description: As Quality Control (QC) Analyst, the incumbent is responsible for successfully creating procedures for operation of QC lab equipment, coordinating the analytical test method validations, performing the analytical testing per established procedures and documenting the results and reports accordingly. The individual will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation. Experience in working in a GMP laboratory environment is preferred. This role regularly interacts with other key functions, senior leadership and external clients.
Key responsibilities will include:
- Creating procedures for operation of various lab equipment
- 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
- Laboratory Control Systems
- Laboratory Investigation
- 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.
Qualification & Experience:
- Associate degree in Science or Engineering, Bachelor’s degree preferred.
- Excellent oral and written communication skills.
- Strong ability and motivation to learn.
- Experience in either the pharmaceutical industry, an operations environment or Quality Assurance, 5 years’ experience preferred.
- Preferred Proficiencies: MS Visio, MS Project, MS Excel, MS Power Point, MS Word (Intermediate and above), or similar software platforms.