What are the responsibilities and job description for the Quality Associate position at Liquidia Technologies, Inc.?
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 arterial hypertension (PAH). 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.
We are looking for a hands-on and experienced Quality Associate. In this role you will be responsible for performing various activities within the Quality Department. The primary function is to ensure all documentation created and completed is as per 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.
RESPONSABILITIES FOR THIS ROLE:
- Draft, review, edit, revise and/or approve QMS documentation including, but not limited to, batch records, procedures, policies, protocols, calibration reports, maintenance forms, minor deviations, minor out of specifications (OOS) and corrective / preventative actions (CAPA).
- Lead investigations for minor deviations, as assigned.
- Disposition raw materials and standard reference materials based on approved specifications.
- Act as system manager for electronic QMS systems (e.g., Electronic Document Management System, Learning Management System) as needed.
- Perform non-complex internal and external GXP audits.
- Support compliance audits by external partners and regulatory agencies
- Coordinate laboratory notebook and logbook system, including notebook review, archiving and organization for easy retrieval.
- Support management of GXP training management system
- Assist in the administration of the instrument calibration system and related documentation.
- Review of completed batch records.
Core Values: Teamwork, Collaboration, Compliance.
EDUCATION AND EXPERIENCE:
- BS degree required, preferably in a technical field.
- 1 years of related pharmaceutical experience
- Must be a detail-oriented person with strong communication and organizational skills.
- 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 organizational levels.
- The ability to thrive in a multidisciplinary team environment is essential for success.
Requirement for this job: COVID-19 vaccination.
Come join an innovative thinker organization where we foster collaboration, have fun while accomplishing our goals and are patient focused!
Liquidia offers a competitive and comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, 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.
Salary : $44,900 - $56,800