QA Validation Technician I
QA Validation Technician I
Posted on :
22-05-2025
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1 Vacancy
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Job Description
Job Description:
Carries out the practical work in the laboratory including method development method validation and trouble shooting. Takes over responsibility for the QC part of projects. Perform required testing on raw materials intermediates and finished products. Support QC chemist to provide the method technology transfer and project preparation work make sure the project runs on time and smoothly.
Responsibilities:
- Transcribe laboratory data from worksheets logbooks and instrument outputs into electronic systems and official records with high accuracy and attention to detail ensuring compliance with cGMP and data integrity principles.
- Review analyze and trend laboratory data from environmental raw material inprocess and final product testing to ensure conformance with specifications and regulatory requirements.
- Ensure accurate timely and compliant documentation of all data in accordance with cGMP and Standard Operating Procedures (SOPs).
- Maintain databases and electronic records for laboratory data ensuring data integrity and regulatory compliance.
- Author revise and review SOPs data review templates and protocols to support consistent data handling practices.
- Partner with QC laboratory staff to investigate data deviations and support root cause analysis and CAPA development.
- Provide data reports summaries and metrics to support production investigations and continuous improvement initiatives.
- Reviews GDP and date integrity to ensure that review and approval of all GxP data generated for projects are managed and evaluated as described in relevant protocol SOP and regulatory requirements.
- Support method and equipment validation through data compilation and statistical evaluation.
- Participate in internal customer and regulatory audits by preparing data packages and responding to datarelated inquiries.
- Provide training and guidance to QC personnel on data handling transcription trending and reporting requirements.
- Assist in datarelated aspects of lab operations including supporting electronic systems (e.g. LIMS CDS) and ensuring data backup and access protocols are followed.
- Identify data quality issues and drive resolution through collaboration with relevant stakeholders.
- Maintain awareness and compliance with FDA EPA and OSHA regulations and company safety standards.
- Support sustainability and safety initiatives by reporting issues and halting unsafe practices when necessary.
- Other tasks as assigned by Manager QA and/or QA Team Lead
Requirements:
-
- Bachelors degree in chemistry Biochemistry Microbiology Life Sciences or a related field.
- Two to four years experience in a GMPregulated laboratory setting with a focus on data transcription analysis or quality systems.
- Proficient in Excel statistical tools and laboratory information management systems (LIMS).
- Strong attention to detail documentation and data integrity principles.
- Excellent organizational communication and problemsolving skills.
Employment Type
Full Time
Key Skills
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