Quality Control Analyst Ii
5 months ago
**Summary**:
**Quality Control Analyst II**
**ZYUS. Advancing the science of well-being.**
**About the Role**
The **Quality Control (QC) Analyst II** is responsible for routine testing for product, raw materials, and packaging, ensuring compliance with current Good Laboratory Practices (cGLP) and performing analytical method development and validation. The QC Analyst will perform material sampling, maintain sample chain of custody, and report results.
**Main Duties/Responsibilities**:
**Perform Analytical Testing**:
- Conduct analytical testing using a variety of instruments such as UHPLC, Mass Spectrometer, Densitometer, and other analytical instruments as required.
**Protocol Development and Summarization**:
- Develop and/or follow lab protocols and efficiently summarize the obtained results.
**Lead Equipment Qualification**:
- Lead the development and execution of protocols for qualifying equipment, guaranteeing their proper functioning and suitability for intended use.
**Train QC Personnel on Lab Methods and Instrumentation**:
- Share expertise by training and educating QC personnel on laboratory methods and instrumentation, ensuring a skilled and knowledgeable team.
**Lead/Review Change Controls, Deviations/Investigations, Risk Assessments**:
- Lead investigations for deviations within the laboratory environment and establish investigative protocols to identify root causes and prevent recurrence.
- Evaluate changes to validated processes and assessing associated risks.
- Lead or review change controls.
**Deviation Reporting and CAPA Participation**:
- Promptly report all deviations from standard procedures.
- Actively participate in the resolution of deviations and contribute to the assignment of Corrective and Preventive Actions (CAPA).
**Perform Internal Lab Audits**
- Conduct internal audits of QC processes and practices, identifying areas for improvement and ensuring adherence to standards.
**Assist in Test Method Validations**:
- Collaborate in the validation of analytical test methods, ensuring compliance with standards.
**Adherence to Laboratory Procedures and Regulations**:
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Ensure the safety and orderliness of the laboratory.
- Adhere to the quality standards governed by cGLP, company Quality Policies, and site Standard Operating Procedures (SOPs).
**SOP Authorship and Review**:
- Author, review, and update SOPs as needed.
- Understand and adhere to complex written procedures governing laboratory activities.
**Documentation Practices**:
- Practice good documentation throughout all aspects and phases of work.
- Provide timely reports for review and actively collaborate with other lab personnel on various projects.
**Material Handling and Inventory Control**:
- Handle materials and exercise control over inventory, including substances under controlled conditions.
**Qualifications**:
- Post-secondary education in Chemistry, Biochemistry, or related field is required with a preference for a bachelor’s degree.
- A Minimum of 2 years of laboratory experience.
- Preferably, experience in a setting adhering to cGMP (Current Good Manufacturing Practice) and GLP (Good Laboratory Practice) standards.
- Chromatography experience would be considered an asset.
**Benefits of Joining Our Team**
At ZYUS, we care about our people. Our total rewards package includes comprehensive benefits, retirements savings, paid time off, on-going training and development opportunities.
**How to Apply
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