Overview
Job Title: QA Specialist
Department: Quality Assurance
Reporting To: Operational Quality Lead
Effective Date: See internal documentation
The QA Specialist will ensure that the testing laboratory complies with all relevant quality management systems (QMS) and regulatory standards related to data generation, laboratory testing, and approval processes.
Responsibilities
* Review, approve, and issue quality control (QC) data to support timely product release. Provide coaching to improve Right First Time performance.
* Perform document control tasks including controlled printing, reconciliation, and archiving.
* Assist in preparation for and participation in audits and inspections.
* Author Good Manufacturing Practice (GMP) documentation.
* Initiate and contribute to quality events such as deviation investigations and change controls.
* Participate in GEMBA walks and process confirmations to enhance compliance and operational efficiency.
Qualifications
* A. Educational Background
* Minimum Requirement: Bachelor of Science or equivalent experience
* Field of Study: Science, Engineering, or other technical disciplines
* Rationale: Required to interpret complex scientific and technical data
* B. Job-Related Experience
* Minimum Requirement: Experience in a regulated environment, preferably GMP, in a role supporting Quality or Manufacturing
* Additional Benefit: Laboratory experience
* Rationale: Necessary for reviewing GMP records and laboratory data
* Proficiency in Microsoft Office
Job Details
* Seniority level: Associate
* Employment type: Contract
* Job function: Quality Assurance and Science
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
Please apply on LinkedIn.
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