QC Bioassay Analyst

QC Analytical opportunity for candidates interested in a new challenge in a cGMP regulatory environment.

We have built a new state of the art Quality Operations laboratory, we are looking for Bioassay Analysts who will report directly to the Bioassay Manager.

The ideal candidate will have 1 year experience in a pharmaceutical laboratory, ideally with experience in cell culture and ELISA. Core to the role is to perform release testing of samples.

Responsibilities:

Work as directed by the Quality Control Bioassay Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Merck Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

Ability to lead/mentor team of lab analysts

Act as testing SME with QC department, leading OOS investigations and supporting troubleshooting activities

Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.

Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.

Operate as part of the QC team performing the allocated testing and laboratory based duties.

The candidate will have responsibilities batch release methods.

Perform various analytical techniques cell culture, ELISA s.

Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.

Provide support with audit/inspection requirements to ensure department compliance/readiness.

Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.

Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 whys etc,

Requirements

Minimum Experience:

1 year of experience in a pharmaceutical laboratory.

A good working knowledge of ELISA method.

A good knowledge of cGMP, GLP, Quality Management Systems.

Preference is demonstrated experience with Lean methodologies in a QC environment.

Minimum Education:

Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline