We are seeking a highly motivated and detail-oriented Quality Assurance and Regulatory Affairs Specialist to join the exciting area of molecular diagnostic products. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. The qualified candidate will support the development and implementation of ongoing activities related to various Quality Assurance (QA)/Regulatory Affairs (RA) objectives with a heavy emphasis on Quality Management System (QMS) administrative and document support. The candidate will maintain/manage electronic and paper-based files.
This role is a part-time fixed-term contract until 31 Dec 2021.
Who we are:
We are a fast-growing life sciences reagents and software company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19. You will join a team of highly talented people in a well-funded, exciting environment.
What you will be responsible for:
- Support Document Control and quality management system (QMS) activities at ChromaCode.
- Maintain all controlled documentation in compliance with document control procedural requirements
- Support template creation and formatting.
- Oversee document through its entire life cycle (inception to archival).
- Check and edit incoming documents and prepare for distribution.
- Create/maintain document filing and organizing systems that are both effective and efficient.
- Ensure proper organization and security of documents (paper and electronic).
- Make available, notify, and distribute documents to relevant recipients.
- Build, improve, and maintain the document control processes through daily interaction with cross-functional teams while meeting the requirements of ISO 13485 and FDA Quality Systems Regulation.
- Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
- Assist Regulatory Affairs (RA) in the update, enhancement, and creation of internal policies and procedures.
- Provide RA administrative assistance, facility establishment & device listing registration, organize regulatory filing, prepare regulatory meeting minutes/agenda and other regulatory administrative tasks as assigned.
- Prepare, collect, or coordinate information and prepare regulatory documentation / contracts for submission to global regulatory agencies, regional affiliates, or to commercial partners.
- On-time delivery of owned QA/RA activities (i.e., document control maintenance, periodic review reminders, RA filings, etc.)
- Implementation of any quality key performance indicator (KPI) improvements as determined through Quality Planning
Your ideal qualifications:
- Bachelor’s Degree (B.A. in a science-related subject preferred)
- Minimum of 2 years related experience required (3+ years related experience preferred)
- Experience with Document Control and regulatory filings
- Experience with electronic quality management systems software preferred
- An understanding of FDA submissions and CE-IVDD technical file documentation requirements, especially pertaining to document control preferred
- Medical device manufacturing, audit/inspection experience preferred
- Previous experience with process development and/or project management of time-critical projects required
- Must have excellent oral and written communication, presentation, and interpersonal skills
- Must provide a high level of partnership and cross-functional collaboration
- Sophisticated organizational skills, attention to detail, and the ability to balance multiple assignments is required
- Experience in a regulated environment (medical device or pharmaceutical) is preferred
- An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control and quality records
- Remote work flexibility with 25% onsite
If interested, please email resume and cover letter describing your qualifications to: People&Culture@chromacode.com.
ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at People&Culture@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf