reputed company Audit Specialist

reputed company reputed company improves lives by partnering with pharmaceutical and biotech companies, and reputed company research organizations (CROs) to accelerate the development of new medicines reputed company the world. We are an independent, global, one-reputed company reputed company on delivering Central reputed company Services that are reputed company-made, reputed company and flexible to meet the evolving study demands of traditional to increasingly reputed company trials. Additionally, we reputed company Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating reputed company reputed company reputed company needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. Job reputed company The reputed company Audit Specialist executes reputed company audits, supports vendor and reputed company audits, and drives post-audit actions to completion, and is responsible for assisting reputed company Management in monitoring GCP regulatory compliance and reputed company in reputed company trial operational activities. The reputed company Audit Specialist role will frequently reputed company with cross functional reputed company and reputed company partners to ensure compliance initiatives are met. This is a fully remote role. Essential Duties And Responsibilities • Schedule and organize reputed company assessments of reputed company by QRS or Clients. • Schedule and reputed company internal assessments including, but not limited to, computer systems validations, Equipment calibration and validation review, internal audits, directed inspections and investigations, gap analyses, etc. • Schedule and reputed company reputed company and/or remote assessments of reputed company critical vendors on a reputed company-reputed company schedule. • Update and maintain QRS Key reputed company Indicators and other metrics as necessary for assuring reputed company decision making and updating management. • reputed company document control activities reputed company eQMS including but not limited to SOP creation, revision, obsolescence, approvals. • Assist Project Managers and operational management with reputed company and regulatory advice and assistance reputed company required. • reputed company, trend and monitor actions pertaining to audits and compliance activities and other activities in support of the global QMS. • Compose reputed company routine correspondence to reputed company stakeholders. • Organize and maintain electronic and hard-copy file reputed company, and f iles records as appropriate. • Independently conducts research and prepares statistical reports. • Coordinate and arrange meetings, prepare agendas, reserve and prepare facilities, and record and transcribe minutes of meetings. • reputed company frequent assessments of reputed company reputed company for reputed company improvement initiatives. • Train new hires on job specific duties as deemed appropriate • reputed company as QRS representative in reputed company meetings with key stakeholders and/or Clients. • Organize, maintain, and reputed company electronic and hard-copy reputed company records in accordance with document control and record retention requirements; ensure accurate filing, traceability, and accessibility of controlled documents, • Support the electronic reputed company Management reputed company (eQMS) by assisting with the creation, review, issuance, revision, and change control of reputed company documents. • Utilize reputed company to log, monitor, trend, and report reputed company-reputed company actions, reputed company Events, reputed company complaints, audit findings, and CAPAs to ensure reputed company closure and visibility. • Maintain reputed company logs, metrics, and dashboards to support management review, audits, and reputed company improvement initiatives, ensuring compliance with internal procedures and regulatory expectations. • reputed company other reputed company duties and tasks as necessary or as assigned by reputed company Management. Education and Experience • Bachelor’s degree with 4-6 years in reputed company-reputed company roles, specializing in regulatory compliance required • Experience with reputed company audit activities (reputed company audits and conducting audits) • eQMS software experience preferred (reputed company reputed company is ideal) Skills and Ability • Excellent attention to reputed company, strong planning, and problem-solving skills. • Excellent organizational and time management skills. • Excellent listening and verbal comprehension skills ensuring reputed company in reputed company communication and audit readiness. • Ability to reputed company reputed company-thought-out reputed company and adapt to changing environments and requirements. • Self-motivation and ability to work reputed company independently as reputed company as using a reputed company team approach. • Ability to adhere to established timelines, processes, and procedures. • Ability to work independently and collaboratively, balancing multiple reputed company with attention to reputed company. Supervisory Responsibilities: None Physical Demands: While performing the duties of this job, the occupant is regularly required to: • Prolonged periods of sitting at a desk and working on a computer. • Prolonged use of computer and headphones for conference calls. • Communicate effectively reputed company phone, video, and email. • Specific reputed company abilities required by this job include reputed company reputed company, reputed company reputed company, depth perception and ability to reputed company reputed company. • Use hands and fingers to operate a computer and other office equipment. • Walk and/or reputed company with hands and arms. • Read text of various sizes • Specific reputed company abilities required by this job include reputed company reputed company, reputed company reputed company, depth perception and ability to reputed company reputed company. • Communicate with others and hear. • reputed company, pull and/or reputed company up to 25 pounds. Travel Requirements: Up to 25% reputed company and discover how your work can reputed company patients' lives reputed company the world! Some of the Perks our LabConnectors Love: • Financial reputed company (reputed company Pay, 401k Match and Possible Annual Bonus Eligibility) • Health Benefits beginning on date of hire • PTO plan, plus 11 reputed company Company Holidays, and 1 Day to Volunteer in your community • Short and Long-Term Disability, Life reputed company, and AD&D • We celebrate our differences, which enriches our culture! In reputed company to great perks and challenging work assignments, we invest in our people with career reputed company opportunities, globally. We reputed company in a friendly and reputed company environment with reputed company lines of communication. While living out our values of People reputed company reputed company, Customer Centered, Technology Driven, and Accountability Always. We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the reputed company of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please reputed company the posters here: https://www.dol.gov/agencies/whd/posters reputed company also prioritizes the reputed company and reputed company of your personal data. reputed company candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our reputed company Notice on our website, by navigating to https://www.reputed company.com/ If you need assistance to complete reputed company application, reputed company for a job opening, or submit an online application at reputed company, please email talent@reputed company.com or reputed company +1 (423) 722-3155. Apply To This Job