Quality Assurance Specialist

Company: Merit
Location: Madison
Posted on: August 7, 2022

Job Description:

Job DescriptionSalary: MERIT is an innovative, global specialty CRO focusing on clinical trial endpoint services in the ophthalmology and respiratory disciplines. Our cloud-based software application, EXCELSIOR, was built specifically for supporting image data collection and endpoint adjudication of ophthalmic, respiratory, cardiology, and oncology clinical trials. We seek employees who are team players, detail orientated, and motivated to help understand and treat ophthalmic disease.We are seeking a Full-Time Quality Assurance Specialist for our North Liberty, Iowa, or Madison, Wisconsin location. This position is available to work from home Remotely!Primary functions include collaborating with Operations and the Quality Assurance Manager to maintain and assist with implementing the Quality Management System (QMS). Ensures the compliance of appropriate quality management tools, implements the related process. Performs internal audits and contractor and vendor assessments including qualifications, on-site audits, and maintenance activities. Assists with on-site client audits and provides training and communications on regulatory requirements to MERIT personnel.Understand the EXCELSIOR product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss, direct and manage task items with the project managers and team membersComply fully with MERIT policies and Standard Operating Procedures (SOPs)Internal audits - conducts internal audits and assists in the development of the internal audit schedule.Client and regulatory on-site visits and audits- assists with scheduling and managing audits as assigned.Vendor and Contractor qualifications and audits - conduct vendor and contractor qualifications and audits including on-site audits, and vendor and contractor maintenance activities.Leads the development, recommendation, review and administration of policies, training and SOPsProvide training for implementation of internal and regulatory requirementsEnsure that SOPs are being followed during daily operations: CAPA, deviations, non-conformances, document control, change control, software development life cycle, validations, training, security, and documentationInterpret and assist in implementing regulatory guidelines into MERIT QMSResponsible for audit responses within framework of internal SOPs and client due datesOther responsibilities may be assigned as required The following are the essential functions of the position but are not all-inclusive.Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.Demonstrates a commitment to maintain safe, clean, and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.BA or BS degree from a four-year college or university with related experience and/or training in a health care, clinical research or service-related environment, or equivalent combination of education and experienceThis successful candidate will have a positive work history, a minimum of 2 years experience in quality assurance in the medical device, pharmaceutical or GxP industry. Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently. Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment. Ability to participate and contribute to a team environment as a team member. Oral and written communication is clear, concise, and effective. MERIT offers a compensation and benefit package that includes paid time off, health, dental, and vision insurance, corporate retirement plan with company match, and flexible schedules. Merit is Equal Opportunity Employer

Keywords: Merit, Madison , Quality Assurance Specialist, Other , Madison, Wisconsin