Join a supportive and growing team within a state-of-the-art Quality Control laboratory supporting the testing of biologics and vaccines. This is an excellent opportunity to join an established pharmaceutical manufacturing environment with a strong focus on quality, compliance and continuous improvement.
The QC Lead Analyst will report directly to the QC Manager and play an important role in supporting the continued development and expansion of the laboratory. Key responsibilities will include analytical method transfers, method validation and commercial product testing. The team operates on a two-cycle shift pattern.
Occasional travel may be required for training purposes.
The ideal candidate will have 4+ years’ experience in a pharmaceutical laboratory, ideally with hands-on experience in ELISA, HPLC and compendial testing, along with relevant laboratory systems and software. A key aspect of the role is performing analytical testing to support the release of key pharmaceutical products.
What you will do
Bring your technical knowledge, initiative and leadership skills to carry out the following responsibilities:
- Work under the direction of the Quality Control Manager, ensuring compliance with company safety policies, cGMP, cGLP, global policies, procedures, guidelines and applicable regulatory requirements in all day-to-day activities.
- Participate in daily QC Tier 1 meetings, ensuring effective communication of testing progress, deviations and other relevant updates.
- Contribute to the writing, revision and implementation of operational procedures, training materials and maintenance procedures across relevant Quality systems, ensuring all work is performed in accordance with approved documentation.
- Work as part of the QC team, carrying out allocated analytical testing and review activities.
- Perform a range of analytical techniques, including but not limited to ELISA, HPLC and compendial assays, in accordance with GMP requirements.
- Peer-review testing documentation, ensuring data integrity requirements are met and QC Right First Time KPIs are achieved.
- Participate in laboratory investigations relating to out-of-specification (OOS) results.
- Support audit and inspection activities, helping to maintain departmental compliance and inspection readiness.
- Participate in internal and external audits and inspections, acting as an auditee for assigned areas of responsibility.
- Drive continuous improvement initiatives and conduct root cause analysis into system failures and substandard equipment performance, using appropriate tools and methodologies such as FMEA, fishbone diagrams and the 5 Whys.
- Collaborate with colleagues to promote a safe, compliant and quality-focused laboratory culture.
What skills you will need
To be successful in this role, you will ideally have:
- A Bachelor's degree or higher, preferably in Analytical Chemistry, Biochemistry or a closely related scientific discipline.
- At least 4 years’ experience working in a pharmaceutical laboratory.
- A good working knowledge of HPLC systems and associated software.
- A good working knowledge of ELISA techniques and SoftMax Pro software.
- A sound understanding of cGMP, GLP and Quality Management Systems.
About the opportunity
You will be joining an established pharmaceutical manufacturing site specialising in the manufacture and commercial supply of vaccines, biologics and small-molecule drug products. The site features modern production facilities, advanced laboratories and temperature-controlled warehousing, supporting high-quality manufacturing and product supply.
The organisation is committed to quality, innovation, continuous improvement and employee development. It values collaboration, technical excellence and the contribution of diverse teams, and is an equal opportunity employer dedicated to fostering an inclusive and supportive working environment.