Senior QC Analyst

Description Overview

In this role you will lead routine physical and chemical analysis of incoming raw materials, in-process bulk materials, finished products, stability, and non-routine analysis as specified.

You will also assist with training and mentoring of other analysts and technicians, and take a proactive role in the investigation of non-compliant products and materials.            

Scope of the Role

Analytical Testing:

• Testing the appropriate materials or product to the approved specification, method, or protocol. This includes the processing and recording of data for completed analysis.
• Peer review and approval of completed analysis where applicable.
• Troubleshooting with problematic analyses and malfunctioning equipment.
• To perform and help others with scientific calculations, assess chemical reactions and interactions within separation science and look at the chemical composition of APIs and excipients to identify the significance this will have when testing.
• Organise, prioritise, and execute own workload to ensure batches are tested and released within specified lead times.

Investigating non-conformance:

• Report on and lead investigations of non-conformance. Any non-conforming materials or products must be contemporaneously reported to management.
• Developing hypotheses or rationale to aid scientific investigations.
• In depth understanding of analytical principles or methodologies. Using scientific knowledge and experience to understand when a process does not work as intended and able to systematically identify a root cause.
• Support in the investigations associated with CAPA (corrective and preventative action) and change controls where appropriate.

Training and Development:

• Training and mentoring of other analysts and technicians. Conducted within parameters of the Laboratory Training procedure.
• Plan and oversee trainee analysts work schedule.

Documentation:

• Writing and reviewing QC related documentation, such as, Certificates of analysis (CoA’s), Stability reports/conclusions, out of specification (OOS) reports, risk assessments, COSHH assessments.
• Writing reports or summaries of analytical and non-routine testing.
• Reviewing and supporting with data interpretation for product quality reviews (PQRs).
• Actioning release at risk where necessary.

Continuous Improvement:

• Participation in continuous improvement projects.
• Assisting laboratory management team with new product introduction (NPI).
• Undertake tasks which support the operation of the laboratory, maintaining cGMP and laboratory cleanliness.

Other:

• Undertake such other reasonable duties as may be required from time to time to support the Perrigo business.

Experience Required

• Experieince liaising closely with key stakeholders in various parts of a large organistation such as Operations, Quality Assurance, Quality Engineering, Process Capability, Regulatory, Research & Development & QP’s.
• Experience working with technical representatives of Contract Givers & Regulators (including MHRA, HSE & BSI), Customers & Suppliers.
• Bachelor’s Degree in a relevant scientific subject or equivalent practical experience.
• Ideally, 3 years of practical industry experience within a similar role.
• Advanced level computer literacy. Knowledge of Microsoft Office packages. Knowledge of statistical software advantageous.