QC Analyst - Client dedicated (18-month contract)

Pharmaceutical Product Development, Inc ,
Stevenage, Hertfordshire

Overview

Job Description

QC Analyst - (on-site Stevenage, UK) PPD has an exciting opportunity for a QC Analyst to join us onsite at one of our clients in Stevenage, Hertfordshire as part of our innovative Functional Service Provider (FSP) programme, as an employee with PPD. You will be dedicated to the client projects, working within their teams, systems and processes on behalf of PPD. The role of this QC Analyst is to contribute to the cell-based bioassay QC laboratory. PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit Key responsibilities: Routine cell culturing to support bioassay testing in accordance with regulatory requirements and agreed schedules Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance. Maintain detailed laboratory records in accordance with current Good Manufacturing Test samples utilising a range of biological cell based tests, in accordance with regulatory requirements and agreed schedules. Provide information on biochemical methods, test specifications and sampling regimes, and the impact they may have on the product. Following correct practice (cGMP) through the use of controlled pro forma or laboratory notebooks. Ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements. Record deviations from the normal practice and out of specification results appropriately and report them to the line manager; assist with investigations product and test anomalies. Deliver and assess formal training programmes for staff and trainees as required. Facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory and responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures. Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area Participate in the validation of test methods and equipment used in analysis to meet regulatory requirements. Basic Requirements BSc in biology, cell biology, virology, biochemistry or related scientific discipline. Experience with bioassay testing; Strong organisational and excellent interpersonal communication skills. Individual should be capable of writing reports related to work completed in laboratory. Demonstrable ability to work in multi-disciplinary, multi-cultural teams At least 1-4 years of analytical testing experience What we offer: PPD offers a benefits package that includes among others, a comprehensive health plan, retirement plans, and other incentives. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves!