Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers and verification, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team.
This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.
Specific Job Duties:
* 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
* With a high degree of technical flexibility, work across diverse areas within the lab
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
* Report, evaluate, back-up/archive, trend and approve analytical data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
* Write protocols and perform assay validation and equipment qualification/verification.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
* Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
* Approve lab results
* May participate in lab investigations.
* May provide technical guidance.
* May train others.
* May contribute to regulatory filings.
* May represent the department/organization on various teams
* May interact with outside resources
* 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
* 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), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
* Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
* Technically strong background in microbiology and aseptic manufacturing
* Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
* Flexibility - the role often encounters changing priorities (also required to work weekend on call - Rota system)
* Experience with Regulatory inspectors and interacting with inspectors desirable
* Demonstrated ability to work independently and deliver right first time results
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.