What are the responsibilities and job description for the GMP Laboratory Equipment Specialist position at ClinLab Staffing?
Job Purpose:
The primary purpose of this Validation Specialist role is to qualify QC laboratory equipment and instrumentation at our new facility for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.
Key Responsibilities:
Requirements:
* Bachelor's degree in relevant scientific discipline (e.g., Chemistry, Biology, Engineering).
* Minimum 3 years of experience in QC validation within a contract research or pharmaceutical environment.
* Strong knowledge of regulatory requirements (e.g., FDA, EMA) and quality management systems.
* Knowledgeable of Data Integrity requirements
* Proven experience in writing validation protocols and reports.
* Familiarity with QC instruments and validation methodologies.
* Excellent analytical and problem-solving skills.
* Strong attention to detail and organizational abilities.
* Effective communication and interpersonal skills.
Why Join Us:
ClinLab Staffing offers a dynamic and supportive work environment, with opportunities for professional growth and development.
The primary purpose of this Validation Specialist role is to qualify QC laboratory equipment and instrumentation at our new facility for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.
Key Responsibilities:
- Conduct validation activities for QC instruments (hardware and software), including calibration, qualification, and verification.
- Develop, write, and execute validation documents (URS, FS, CS) and protocols (IOPQs), ensuring they meet regulatory requirements and internal standards.
Requirements:
* Bachelor's degree in relevant scientific discipline (e.g., Chemistry, Biology, Engineering).
* Minimum 3 years of experience in QC validation within a contract research or pharmaceutical environment.
* Strong knowledge of regulatory requirements (e.g., FDA, EMA) and quality management systems.
* Knowledgeable of Data Integrity requirements
* Proven experience in writing validation protocols and reports.
* Familiarity with QC instruments and validation methodologies.
* Excellent analytical and problem-solving skills.
* Strong attention to detail and organizational abilities.
* Effective communication and interpersonal skills.
Why Join Us:
ClinLab Staffing offers a dynamic and supportive work environment, with opportunities for professional growth and development.
