
Scientific Laboratory Specialist
1 day ago
Job Opportunity:
We are seeking a skilled Analytical Lead to join our laboratory team.
The successful candidate will be responsible for ensuring that all laboratory operations are performed in accordance with ISO 17025 and cGMP requirements.
This role involves directing day-to-day project activity, gathering and analyzing scientific data, and ensuring accurate and precise results are achieved and properly reported.
- Technical Leadership: Provides strong technical guidance to technical personnel.
- Method Development: Leverages expertise in method development and validation of new test procedures.
- Data Analysis: Evaluates analytical results to form interpretations of data and renders scientific opinions.
- Regulatory Compliance: Serves as a subject matter expert in regulatory compliance.
- Customer Collaboration: Collaborates with customers on technical services and performs site visits as required.
- Document Preparation: Prepares documents, including methods, procedures, and study protocols.
- SOP Adherence: Maintains adherence to regulatory requirements and ensures SOPs are up-to-date.
- Issue Resolution: Identifies and resolves issues related to test procedures and investigations.
- Audit Participation: Participates in quality audits and system audits.
Qualifications:
To be considered for this role, you should have a Bachelor's degree in a relevant field, with a Master's preferred but not essential.
A minimum of 2-6 years of relevant QC microbiological experience in an ISO 17025/GMP laboratory environment is required.
Candidates should possess good knowledge of ISO 17025, cGMP, and other regulatory guidelines, as well as excellent communication and interpersonal skills.
Experience in method validation, method transfer, qualification activities, and regulatory compliance is highly desirable.
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