QC Analyst York, England
Job description
Senior QC Analyst (York)
About LabCorp Drug Development:
As a leading contract research organization, LabCorp provides comprehensive drug development solutions for a range of industries. We are a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Together with our clients, we support the development of innovative, life-changing treatments.
The Role:
Our UK site in York, is currently recruiting for a Senior QC Analyst to join the BioPharmCMC team.
Within the York BioPharmCMC business unit; the Protein Chemistry and Bioassay departments provide dedicated release and stability testing from preclinical through to the commercial phase of Small and Large Molecule pharmaceutical products, using a variety of analytical techniques including HPLC, Capillary Electrophoresis, Compendial Techniques, ELISA and Cell Based Assays. In addition, the department also provides method development, transfer, phase appropriate validation of analytical methods.
We structure ourselves to deliver scientific expertise to our clients; collaborating closely with them to support the development of medicinal products through the drug development process and onto market.
The Senior QC Analyst role within the York BioPharmCMC department is a senior laboratory scientist position. You will perform analytical testing using a range of techniques for pre-clinical, clinical and commercial studies.
Job Responsibilities:
- Performing analytical testing on small molecules and large protein molecules using the following analytical techniques: HPLC, Capillary Electrophoresis, Compendial Techniques, ELISA and Cell Based Assays.
- Performing analytical method validation activities.
- Recording of data on the appropriate documentation with strict adherence to current Good Manufacturing Practice (cGMP).
- Quality Control review of GMP analytical data and associated documentation.
- Lab level oversight and organisation of client projects; including organising study files and study data throughout the data life cycle, performing stock checks and ordering consumables/reagents, assisting with writing and updating a variety of documents.
- Working with Quality Control (QC) Scientists to perform a wide range of analytical techniques in accordance with GMP regulatory requirements, to undertake data processing, and to deliver client projects.
- Troubleshooting of equipment and analytical methods.
- Training, mentoring and coaching of junior laboratory analysts and other team members.
- Providing technical guidance and help the team troubleshoot analytical methods.
- Writing and updating Analytical methods and Standard Operating Procedures.
- Involvement with the Quality Management System (QMS) for deviation, change control, lab investigations and associated change actions (CAPA).
- Assisting with the maintenance of laboratory equipment.
What Labcorp Drug Development can offer you:
- A comprehensive onboarding training plan covering laboratory, technical and regulatory training packages.
- Unsurpassed career development opportunities, with the ability to develop your technical and managerial skills.
- Ability to work with a variety of different clients on wide ranging projects.
- Competitive salary dependent on experience, and a comprehensive benefits package including contributory pension.
Key Information:
- Position includes a 6-month onboarding & probationary period during which working hours are 8:45am – 5pm, based at our site in York.
Prerequisites:
- Required: Scientific degree (Biochemistry, Chemistry, Biology, Molecular Biology, Biomedical Sciences etc) OR relevant scientific industry experience.
- Required: Previous work experience in a Pharmaceutical Analysis role.
- Required: An understanding of health and safety policies and of GMP/GLP/GCP.
- Required: Ability to multitask and prioritise workload, with excellent attention to detail.
- Required: Exceptional communication skills.
- Required: Ability to integrate well within an established and fast growing team.
- Required: Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
- Desirable: Strong analytical experience using any of the following techniques: HPLC, ELISA, Cell Based Assays, Capillary Electrophoresis and compendial techniques.
- Desirable: Direct Line Management of junior staff.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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