Quality Assurance Specialist

Job DescriptionQA Specialist is responsible for ensuring compliance with protocols, federal regulations, industry guidelines and company procedures. Maintain knowledge of Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations.Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documentsWorks directly with international coordinators and project managers to ensure accurate documentation is performed for clientsPerforms review of marketing and recruiting documentationPerforms audit of study material receipt and return/destructionPerforms in clinic audit of study proceduresConducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH compliancePerforms review of Final ReportAssists with auditing the company training filesMonitors internal studies and alternative sitesAssist with documentation of non-conformities, corrective actions, and preventive actionsCritical in training of new departmental staffOther duties or tasks assigned by managerWork with all involved parties to ensure that both the equipment and operational needs are met.Oversee that the lab safety and orderly contact and take prompt corrective action when unsafe conditions, practices, or equipment are reported or observed.Encourage prompt reporting of health and safety concerns.Qualifications:QualificationsBachelor's and min 1-3 years of relevant experienceDemonstrated ability to understand clinical studiesExcellent organizational, attention to detail, interpersonal skills, and possesses a high level of multi-tasking capacitiesKnowledge of GCP ICH/GLP guidelines and Federal Regulations related to the conduct of Clinical Trails, NIH trainingAdditional InformationSGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.