We are looking for an outstanding QA Associate to join our Operations Team. The QA Associate will perform finished product inspection and assist with shipping. This role may also involve incoming raw material inspection. The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast-paced startup environment.
What You’ll Be Doing
- Assist with writing work instructions and procedures, document control materials management, chage management, corrective action and preventative action (CAPA) management
- Ensure training records are up to date
- Identify and implement process improvements, as necessary
- Ensure manufacturing equipment maintenance is performed and recorded.
- Ensure that standard operating procedures are followed and are appropriate for process
operations.
- Perform risk analysisPerform effectiveness checks of completed corrective and preventive actions, as needed
- Ensure compliance with company quality systems, and other company policies
- Prepare for and participates in compliance audits
- Follow regulatory and ISO 13485 requirements
What you will bring to the Team:
- BS in Biology Molecular Biology, Biochemistry, Chemistry, Bioengineering or a closely- related field or equivalent work experience
- Between 2-4 years of relevant industrial experience in quality assurance.
- Knowledge of quality standards (ISO 9001, ISO 13485)
- Preferably familiar with: Google Suite – mail, docs, drive, sheets, Atlassian- Confluence, JIRA. Microsoft- word, excel
- Experience in preparing for or participating in compliance audits and/or inspections by regulatory agencies.
- Excellent written and verbal communication skills
- Ability and desire for problem solving and decision making in a cross-functional team setting.
- High attention to detail, excellent organizational skills, and ability to work on multiple projects with tight deadlines.
- Excels in a fast-paced, team-oriented, and collaborative environment.
- Proven ability to establish collaborative working relationships; team-oriented, but able to work independently
