QC Analyst

Summary

The candidate must have superior technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product.
The candidate must have prior experience of working in an IMB/FDA regulated facility.

General Scope of Responsibilities

• Reporting to the QC Team Leader the person will be responsible for the following;
• Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
• Rapid turnaround of samples to meet manufacturing needs.
• Performing data review and approval.
• Providing support and advice to manufacturing on QC related topics.
• Initiating and leading investigations where required.
• Initiates and completes, CAPAs and Change Controls in accordance with site procedure
• Writes new and updates current procedures on electronic documentation system.
• Providing training to other analysts and to manufacturing personnel.
• Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
• Proactively identifies and implements lab process improvements.
• Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
• Supports Team leader on day to day testing operations.

Preferred Testing Experience

• Bioburden
• Endotoxin
• Sterility Testing
• Microbial Identification using genetic methods

Key Competencies Required

• Adaptable and flexible
• Collaboration and team work
• Maintains the highest standards of ethical behaviour
• Clear communication skills
• Results and performance driven
• Holds self accountable for compliant and flawless execution
• Problem solving and attention to detail
• Good time management
• Good organisational skills
• Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc,

Qualifications and Experience Essential

• The position of QC analyst requires a third-level qualification (Minimum: Primary degree in a science discipline).
• A minimum of 2 years experience within the Pharmaceutical Industry
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.