We are seeking a skilled Quality Assurance Analyst to join our team. This is an exciting opportunity to work in a fast-paced environment and contribute to the success of our organization.
About the Role
The Quality Assurance Analyst will be responsible for ensuring that all laboratory activities are conducted in accordance with Good Manufacturing Practice (GMP) guidelines. This includes the setup and execution of bioassay product testing, as well as the validation of assays at our manufacturing site.
Key Responsibilities
* Qualify new laboratory equipment as required
* Perform GMP compliant and timely transfer of analytical methods
* Generate necessary documentation to support ongoing operation of the QC laboratory
* Complete training of other analysts on test methods to be transferred
* Perform sample analysis in accordance with standard operating procedures (SOPs)
* Coordinate the use of external test laboratories when required
* Maintain and import laboratory reagents, media and supplies
* Conduct laboratory investigations and generate reports in response to invalid assays, deviations, OOS/OOT results
* Initiate and complete CAPAs and Change Controls in accordance with site procedures
* Present analytical data/trend reports clearly and concisely to management
* Provide out of hours On Call support for Critical Quality Impact Systems
Requirements
To be successful in this role, you will need:
* A background in Analytical Method Development, Validation and/or Statistical Quality Control
* An understanding of GMP, ICH and compendia regulations and guidance's
* Demonstrated ability in leading root cause analysis and effective investigation practices
* Excellent problem solving (facilitation and application of tools), risk management and decision-making skills
* Experience in laboratory based in aseptic techniques
* Excellent collaboration skills
* Excellent attention to details and significant data review experience essential
* Excellent technical writing skills including deviation reports and validation reports
* Effective time management and multi-tasking skills
* Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail
* Excellent communication skills, both verbal & written
* Adaptable and flexible, willing to travel when needed
Essential Education and Experience
You will need:
* At least 3 years' experience in the biotechnology and/or pharmaceutical industry, with operational experience of quality laboratories and/or new product/assay introductions
* Demonstrated competency in bioassays including polymerase chain reaction (qPCR and RT-PCR) and enzyme linked immunosorbent assays (ELISA)
* Experience in immunological assays such as viral titrations and cell-based bioassays is an advantage
* Experience of analytical transfer programs and method development/validation
* Experience in authoring, review and execution of analytical and process validation studies and reports
* Proficient in written and spoken English
Desirable Education and Experience
It would be beneficial if you had:
* A minimum of an Honours degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceuticals)
* A Master degree is an advantage