ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.
ERT is looking to hire a Quality Analyst for our Boston or Pittsburgh office to execute standard oversight of ERT’s Corrective and Preventive Management program.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensure integrity of Quality System processes for CAPA System in order to maintain facility certifications.
- Support the enhancement and implementation of related quality/business system (ISO 9001); internal auditing, document control, corrective action, customer complaint processing, and continuous improvement activities.
- Provide guidance on CAPA System requirements and expectations; actively promote a team approach to the CAPA process across all departments.
- Establish and assign ownership for audit findings and issues investigations and CAPAs. Monitor and assist with closure of CAPAs; Record the results of actions taken and verifies the effectiveness.
- Facilitate root cause analysis and other problem solving activities to identify effective corrective actions and process improvements.
- Provide support for the effective completion of CAPAs and Investigations.
- Prepare reports by collecting, analyzing, and summarizing data; Maintains tracking & trending for CAPAs.
- Supply training on systems and/or processes related to CAPA System.
- Travel: 10% between ERT locations
OTHER DUTIES AND RESPONSIBILITIES:
- Collaborate with CAPA administrators across offices.
- Participate in CAPA system improvements.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
- Bachelor’s degree in Quality, Science, Health Care, or related field with a minimum of 3 years’ experience in working with quality systems; or at least 5 years’ work experience within a manufacturing or service environment operating a QMS compliant to ISO 9001/ISO 13485 standard.
- Working experience in quality assurance department preferred.
- Experience managing CAPA’s and complaints; Working knowledge of formal problem solving tools and appropriate application of tools.
- Basic knowledge of 21CFRPart 11, 21CFR820, ISO 9001/13485 and/or other applicable regulatory standards.
- Team oriented with excellent communication (written and verbal), interpersonal and organizational skills.
- Strong attention to detail/accuracy and set priorities and effectively perform a variety of tasks simultaneously.
- MS Office applications.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.