CLOSED: Quality Assurance Associate at Redenlab
Redenlab is seeking an experienced Quality Assurance Associate to join our growing Regulatory Affairs & Quality Assurance Team. Redenlab is one of the world’s leading providers of speech and language tests for use in human research trials. Redenlab provides its products and services to pharmaceutical industry partners and healthcare institutes.
We are looking for Quality Assurance Associates / Quality Engineers with experience in ensuring compliance to GCP, FDA, Medical devices and other applicable regulatory and/or industry requirements.
- Assist in establishing and maintaining the effectiveness of the quality management system.
- Work with and provide necessary guidance to all the departments in creating, revising, implementing, and obsoleting procedures and specifications.
- Coordinate and maintain Quality Documents and Records per company internal procedure.
- Carry out internal audits per established schedule.
- Lead and coordinate regulatory and customer audits as and when required, work with relevant departments to provide audit responses within requested timeline and close resultant findings/process gaps.
- Work with applicable departments to perform vendor evaluation/re-evaluation.
- Manage Deviation, Non-conformances, and CAPA.
- Assist in regulatory activities such as customer complaints, recall, and vigilance reporting.
- To act on behalf of the Sr RAQA Manager whenever required (including but not limited to approval of validation reports and quality documents).
- Create validation plan and validation report, coordinate with applicable stakeholders for review and approval.
- Perform QA verification and validation activities of clinical trial and medical devices software products.
Qualifications & Experience
- 4+ years of experience in the Quality Assurance field (experience in IT/Pharmaceutical area will be an added advantage)
- A degree in Science or equivalent
- Experience working within a pharmaceutical/clinical trials environment or regulated industry, knowledgeable in 21CFR Part 11, medical devices requirements and ICH-GCP requirements.
- Experience in internal audits and coordinating external audits.
- Experience in preparing and reviewing validation plan and validation reports
Skills & Expertise
- Ability to quickly understand and evaluate user stories, workflows and wireframes.
- Good communication skills – work collaboratively and development counterparts and others within the team.
- Exceptional problem-solving skills – creative out-of-the-box thinking, and comfort evaluating and deploying new technologies.
- Experience working with Confluence and Jira (Atlassian).
- Solid ability to work effectively under pressure and meet tight deadlines.
- Ability to adapt and learn new technologies.
- Ability to train and foster team environment to all employees
- Ability to work efficiently and independently
- Very analytical and detail oriented
- Remote Work Practices: Redenlab is a virtual first company. Redenlab employees can work from anywhere, however East Coast of Australia is preferred for time zone alignment.
- Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position.
Who we are
Redenlab is an agile biotechnology company based in Melbourne, Australia with team members in the USA and Europe. We are global leaders in clinical trial speech analytics, having pioneered objective measurement of communication in industry driven drug discovery. Working together, we’ve become one of the world’s leading research-focused speech neuroscience groups.
Redenlab embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. Redenlab is an equal opportunity employer.
Location: Remote / Australia
Schedule: Part time / casual
Applications close 1 October 2021.