What are the responsibilities and job description for the Quality Assurance Lead position at Liquidia Corporation?
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Job Summary
The Quality Assurance, Lead position (Swing 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
Requirements
Education and Experience
- BS degree in life science or technical discipline
- 8 years of relevant work experience in a current Good Manufacturing Practices (cGMP), environment with progressive responsibilities
- GxP leadership experience preferred
- Experience in a variety of QA responsibilities preferred
Knowledge, Skills and Abilities
- 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
Benefits
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note :
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
