Inspiration, imagination, and innovation. Here at Aerie Pharmaceuticals, we share this passion for finding new approaches to protecting vision. United by great science, deep clinical insight, and a singular focus on your ophthalmic needs, we see the possibilities ahead and invite you to join us in creating the future of eye care.
We are currently seeking a Clinical Quality Assurance Specialist to join our team in Irvine, California. Under general supervision, the Clinical Quality Assurance Specialist will support Quality oversight of clinical operations and regulatory filings.
Essential Duties & Responsibilities:
- Review clinical study documentation (including, but not limited to, clinical study reports, Investigator’s Brochures, regulatory submission materials), promotional materials, and publications (abstracts/posters/manuscripts) to verify accuracy of the information presented against source documents.
- Utilizing independent judgement and discretion, creates and reviews Quality-related documents affecting products, including, but not limited to, batch records, temperature excursions, and shipment records.
- Maintain a working knowledge of Clinical and Quality procedures and documents to assist with reviews.
- Liaise with cross-departmental authors/reviewers on resolution to document reviews. Makes suggestions and recommendations for resolution.
- Support maintenance of Quality Management Systems, including procedure development/revisions, CAPA/non-conformance, management review data trending and analysis, and training programs.
- Support clinical site audit and supplier management programs, including maintenance of audit schedules.
- Participate in internal audits.
- Provide support to Quality and other functions during regulatory inspections.
- Assist in other Quality activities as directed.
Minimal travel required (approximately 10%)
Knowledge, Skills & Abilities
- Strong attention to detail with the ability to work in a regulated environment.
- Excellent PC skills with proficiency with Microsoft Word and Excel and the ability to learn other software systems utilized by the company.
- Must have good verbal, written, and interpersonal communication skills.
- Self-starter, able to work independently with minimal supervision or in teams.
- Must have the ability to work at a fast pace, work with interruptions, deal effectively with confidential information, and understand and implement written and verbal instructions.
- Must be able to balance multiple routine tasks simultaneously to achieve goals and satisfy customers and recognize when a shift in priority is needed.
- Ability to read, develop, and understand procedures and other controlled documents.
- Knowledge and understanding of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and/or International Conference on Harmonization (ICH) guidelines is a plus.
- Flexibility to work on issues of diverse scope and apply previous knowledge gained to multiple tasks.
- Demonstrates the ability to identify issues and takes initiative to recommend solutions.
- Must be willing to work late or during weekends, if needed.
Education & Experience
Specialist I – B.A. or B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology and 0-2 years related work experience.
Specialist II - B.A. or B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology and 3-5 years related work experience.
Training to pertinent quality-related procedures, documents, and methodologies, safety, and GMP/GLP/GCP/ICH requirements.
Physical Demands and Work Environment
The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or finger, handle, or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. The noise and temperature level in the work environment is usually moderate.
Standard office environment with multiple floors with stairs and elevators.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.