The successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance.
Duties are as follows but not limited to:
- Endotoxin testing of water, in-process and drug product release samples
- Bioburden testing of water & in-process drug product samples
- Sterility testing
- Water sampling
- Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
- Writing technical reports
- Perform analytical testing as a main priority with efficiency and accuracy
- Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
- Write protocols and perform assay validation.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
Basic Qualifications:
- Bachelors degree in a science discipline
- Biopharmaceutical QC experience in a microbiology lab
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Preferred Qualifications
- Experience working in endotoxin, bioburden or sterility testing
- Proficient in GMP systems such as LIMS Labware & LMES
- Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
- Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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