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Quality Assurance Associate
2 weeks ago
**Quality Assurance**
**Summary**
The QA Associate is responsible for conducting and reporting quality assurance audits as scheduled. The QA Associate supports the QA department in assessing compliance of clinical studies with the applicable regulations, guidelines, study protocols, study workplans and internal SOPs and policies.
**Responsibilities**
- Performs audits of facility and studies for compliance with Good Clinical Practices (GCP), Good Clinical Laboratory practices (GCLP) Standard Operating Procedures (SOPs), clinical protocols, applicable regulatory documents, and guidelines (FDA, EMA, CAP/CLIA, ISO, Health Canada etc.)
- Reviews SOPs, Deviations/event Investigations, CAPAs, change control documents to ensure compliance.
- Audits study workplans, performs in-life process audits, study data audits and study reports.
- Conducts facility audits including equipment maintenance, training records, computer software validations (CSV),as applicable
- Performs supplier qualifications as applicable
- Keeps management informed of all findings and follows up on corrective action implementation.
- Assists in the writing or revision of QA SOPs, as applicable.
- Reviews QMS SOPs to ensure SOP contents are clear and consistent.
- Assists QA Management in hosting sponsor audits and regulatory inspections.
- Assist QA Management in generating metrics for quality management reviews.
- Assists QA department in the training of personnel on SOPs and GxPs as applicable
- Coordinate and interact with other department to ensure corporate, departmental and study goals are met.
- Coordinate and interact with other department to ensure corporate, departmental and study goals are met.
**Education**
- University degree in a scientific area, or equivalent.
**Main Requirements**
- 1-2 years QC/QA experience, preferable in a pharmaceutical/regulated environment.
- Experienced writing and reviewing SOPs.
- Clear and concise written and verbal communication in English
- Knowledgeable on Drug Development, Validation of Analytical methods, Quality Assurance and Regulatory Compliance.
- Experienced in various experimental techniques an asset including Immunoassays, Mass spectrometry etc.
- Knowledge of US FDA, EMA and Health Canada requirements on the conduct of clinical studies as they pertain to the activities of CellCarta.
- Detail Orientated, excellent investigation and troubleshooting skills.
- Strong Commitment, self-motivated
- Excellent Organization Skills
- Proven Flexibility to adjust to shifts in priorities, multitask while maintaining levels of quality.
- Ability to work well in a team environment.
- Ability to identify and/or resolve quality issues in a proactive, diplomatic, flexible, and constructive manner.
- Ability to design and implement quality processes and continuous improvement initiatives.
**Working Conditions**
- Actual job location is in Baulkham Hills, NSW 2153.
**Benefits**
We offer a wide range of benefits including:
- Competitive Compensation Package;
- Employee Annual Incentive Plan (EAIP);
- Professional, Dynamic, and Stimulating Work Environment.
**About CellCarta**
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world
**Join us as we make an impact on patient therapy**
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