**Job Title:** QC Lab Analyst
We are seeking a highly skilled and experienced QC Lab Analyst to join our team. This role will be responsible for the setup and execution of bioassay product testing and supporting assays at our manufacturing site.
The ideal candidate will have significant practical and academic experience in test method/assay development in the biotechnology and/or pharmaceutical industry. Excellent interpersonal skills, ability to manage their own time, work to deadlines, and produce high-quality results are essential.
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.
Required Skills and Qualifications:
* A background in Analytical Method Development, Validation, and/or Statistical Quality Control.
* An understanding of GMP, ICH, and compendia regulations and guidelines.
* Demonstrated ability in leading root cause analysis and effective investigation practices.
* Excellent problem-solving, risk management, and decision-making skills.
* Experience in laboratory-based aseptic techniques.
* Excellent collaboration skills.
* Excellent attention to detail 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 task completion, trouble-shooting skills, and excellent attention to detail.
* Excellent communication skills, both verbal and written.
* Adaptable and flexible, willing to travel when needed.
Benefits:
* Competitive salary and benefits package.
* Ongoing professional development and training opportunities.
* Collaborative and dynamic work environment.
About Us:
We are a leading engineering consultancy company specializing in project management, talent solutions, and commissioning qualification and validation services.