An exciting opportunity has arisen for a QC Analyst to join a Quality Control In Process team within a GMP-regulated manufacturing environment. This role offers exposure to both Drug Substance and Drug Product manufacturing processes in a fast-paced, highly compliant setting.
The QC In Process team is responsible for delivering in-process analytical and microbiological testing to support manufacturing operations. The team also conducts testing on incoming raw materials and packaging components to support downstream production activities.
Due to the continuous nature of manufacturing operations, this role operates on a 4-cycle shift pattern, supporting 24/7 production.
The team operates in a collaborative, high-performing environment, where individuals are cross-trained, empowered, and focused on maintaining high standards of quality, compliance, and safety. There is a strong emphasis on continuous improvement, standard work practices, and 5S methodology.
This position requires a proactive and motivated individual with strong organisational skills and the ability to thrive in a dynamic manufacturing setting.
Responsibilities
Perform primary review of QC raw data and trend analytical results
Prepare protocols, reports, and summaries, including documentation for regulatory submissions
Draft, review, and update Standard Operating Procedures (SOPs)
Act as a technical subject matter expert (SME) and provide training and guidance to team members
Evaluate analytical and microbiological data against predefined acceptance criteria
Lead and document laboratory investigations through to resolution
Maintain laboratory readiness for audits and regulatory inspections at all times
Support and participate in regulatory inspections as requiredCollaborate cross-functionally with Manufacturing, Quality Assurance, Facilities, and external vendors
Perform additional duties as required
Requirements
Bachelor’s degree in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience or Master’s degree in a scientific or engineering discipline with 3+ years of relevant cGMP laboratory experience.
Strong written and verbal communication skills
Customer-focused mindset with accountability for quality, accuracy, and timely delivery
Ability to work independently and under pressure in a fast-paced environment
Team-oriented, with active contribution to team development and continuous improvement initiatives (e.g., standard work, 5S)
Proven ability to achieve goals within a high-performing team environment
Adaptable and flexible in response to evolving operational needs
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