Senior Quality Assurance Associate
Liquidia CorporationWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
The Senior Quality Assurance Associate (Second Shift 1:00 pm – 11:00 pm Monday – Thursday) is responsible for performing activities within the Quality Department. The primary function is to provide Quality Assurance oversight and support to Manufacturing Operations, Quality Control, and other functions. This includes providing on-the-floor support, collaborating with the Manufacturing team to address concerns in real time, document review, and project support. This position requires a decisive, detail-oriented person with strong communication and organizational skills.
Responsibilities
- Provide Quality Assurance oversight and support for manufacturing and Quality Control during Swing Shift activities
- Create, revise, review and approve documentation in Quality Assurance operations, including batch records, deviations, OOS, CAPA, protocols, and change controls
- Lead investigations for quality exceptions, as assigned
- Data review as necessary
- Write, edit, review, approve, and implement Standard Operating Procedures (SOPs) and Quality Policies
- Perform internal systems and compliance audits
- Support regulatory inspections
- All other duties as assigned
Qualifications
- Required: 5+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities
- Preferred: GxP leadership experience
- Preferred: Experience in a variety of QA responsibilities
Skills
- Requires thorough understanding of Quality System requirements in support of cGMP regulations
- Detail oriented with strong interpersonal, oral and written communication skills
- Ability to make sound quality decisions based on risk analysis and regulatory/procedural requirements
- Ability to organize time for multiple tasks in a dynamic environment
- Ability to work effectively under matrix organization with multiple deadlines
- Work proactively to lead the quality effort at the company
Education
- BS degree in life science or technical discipline