Quality Assurance Associate

Quality Assurance
Are you looking to make your next career move? CellCarta, a Contract Research Organization, is hiring a Quality Assurance Associate to join our dynamic team. As a QA Associate, you will have the opportunity to use your expertise and skills to ensure that our services meet the highest industry standards. Come work with a team of talented individuals who are committed to making a positive impact on human health and well-being. Apply today and take the first step towards an exciting new career with CellCarta
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, NSW2153.
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
CellCartais 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
The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, "CellCarta"). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta. CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact
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