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QC Specialist
2 weeks ago
Analytical Quality Assurance Specialist
Main Objectives:
- Evaluate and improve analytical methods to ensure quality and consistency.
- Analyze quality control issues and implement corrective actions.
- Develop and maintain analytical documents and procedures.
- Qualify and validate analytical equipment for accuracy and reliability.
- Train and mentor personnel in analytical techniques and documentation.
- Review and approve team member documentation as required.
Compliance and Governance:
- Establish and maintain accurate documentation, including SOPs and validation records.
- Own quality systems actions (IR's, CAPA, CC) to ensure timely resolution and performance tracking.
- Participate in internal and external audits and address audit findings.
- Identify opportunities for process improvement and implement changes for increased efficiency and compliance.
Background and Qualifications:
- Minimum 2 years of experience in the pharmaceutical or medical device industry.
- Degree (or equivalent) in Chemistry, Microbiology, or related field.
- Experience in analytical quality assurance with focus on quality control and method evaluation.
- Proven expertise in analytical equipment qualification and data integrity.
- Familiarity with QC systems and processes, particularly LIMS, MODA, and Veeva.
- Track record of data compilation, review, and reporting.
- Knowledge of data integrity requirements for QC and regulatory compliance.
- Project management skills, including leadership, oversight, and collaborative roles.
Skills and Expertise:
- High level of attention to detail with emphasis on precision and accuracy.
- Self-motivated and goal-oriented with high accountability.
- Technical problem-solving skills with ability to analyze complex data sets.
- Strong organizational skills with ability to prioritize tasks and manage multiple projects.
- Ability to work collaboratively in a team environment.