Quality Assurance Document Control Associate

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 Document Control Associate position is responsible for performing various activities within the Quality Department. The primary function is to ensure all documentation created and completed is as per the company Quality Management System (QMS). This includes drafting and approving procedures and assessing compliance of manufacturing, testing, and/or clinical activities. This position requires a detail-oriented person with strong communication and organizational skills.

Responsibilities

• Maintain and organize QA documents, ensuring they are up to date, properly versioned, and accessible. Process document change requests and manage approvals
• Support audits by ensuring documents comply with regulatory standards and assist in preparing documentation for inspections
• Continuously improve document control processes and recommend improvements
• Draft, review, and approve QMS documentation, lead investigations for minor deviations, and manage electronic QMS systems
• Perform non-complex audits, support compliance audits, and manage laboratory notebook and logbook systems
• Coordinate laboratory notebook and logbook system, including notebook review, archiving and organization for easy retrieval
• Support management of GXP training management system
• Review of completed internal and external (for example, CMO) batch records

Requirements

Education and Experience

• BS degree required, preferably in a technical field
• 1 years of related pharmaceutical experience

Knowledge, Skills, and Abilities

• Must be a detail-oriented person with strong communication and organizational skills
• Must be familiar MS word, excel and MS office tools
• Knowledge of QMS systems such as Veeva Basics, ETQ , CMMS is a plus
• Knowledge of commonly used concepts, practices, and procedures within the compliance field is preferred
• Experience with ERP systems, batch record issuance/review processes preferred
• Relies on instructions and pre-established guidelines to perform the functions of the job
• Applies knowledge (as it is gathered) and guidelines (with supervision) to assess compliance
• Ability to interact with colleagues at multiple organization levels and thrive in a multidisciplinary team environment is essential for success
• Ability to organize time for multiple tasks in a dynamic environment and work effectively with multiple deadlines

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.