Your ResponsibilitiesCarry out microbiological and biochemical analytical analysis of drug substances, detergents/disinfectants, gases, and raw materials in accordance with the valid testing procedures and according to cGMP requirements/local procedures using good aseptic practices.Sampling and analysis of the plant water systems for Bioburden, Endotoxin and chemical parameters.Environmental monitoring of the site's cleanroom suites.Carry out method transfers and participate in the validation of microbiological/biochemical/analytical test methods as required.Ensure that laboratory (samples, equipment and reagents) is correctly maintained to cGMP/local procedures and good hygienic practices and that calibrations are performed at the designated frequencies in accordance with cGMP.Ensure timely investigation and closure of out-of-specification/expectation (alert/action)/trend results to cGMP/local requirements via the use of the current cGMP deviation management systems.Ensure correct data entry to the current Laboratory Information Management System.Ensure that all target dates and key quality performance indicators are met.Where necessary, train other analysts on microbiological, biochemical, and analytical techniques and equipment.Maintain laboratories, desk areas, locker area, and tearoom to a high housekeeping standard.Write and maintain quality-related documentation including QC records, change controls, laboratory investigation reports, deviations, risk assessments, and environmental monitoring and water system trending reports in accordance with cGMP and standard operating procedures.Participate/Complete cGMP and safety risk assessments to ensure adherence to cGMP/local procedures and safety (including biosafety) requirements.Follow relevant safety/biosafety procedures as always required, including the dress code. RequirementsBSc in Microbiology or Biological Sciences.Minimum 1 year work experience in a GMP environment.Preferable to have experience in analytical testing techniques such as (Endotoxin, Bioburden, Environmental Monitoring etc).Professional requirements: familiarity with current Good Manufacturing Practices and sound knowledge of analytical technologies.Ability to work on own initiative essential. Closing Date15/12/2024
Why consider Sterling?Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast-growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
Be caring. Be transparent. Be willing. Be reliable.
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