Document Control Specialist - Quality Quality Assurance Carlsbad, California Description At GenMark, were changing the diagnostics landscape, combining out-of-the-box thinkers and game-changing technology to revolutionize patient care. Our work atmosphere is dynamic, fast-paced, and patient-focused. We encourage teamwork, while reinforcing the importance of individuality, and encouraging an entrepreneurial spirit. GenMark is a leading provider of automated, multiplex molecular diagnostic testing systems. Utilizing GenMark's proprietary eSensor detection technology, GenMark's XT-8 and ePlex sample-to-answer systems are designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. Position Summary The Document Control Specialist executes activities to maintain integrity of the Quality Management System. Essential Duties and Responsibilities: * Member of a team responsible for coordinating and executing all activities necessary to maintain compliance with GMP and/or ISO 13485 and the integrity of the Quality Management System * Maintain controlled copies of Quality documents in the files and in electronic databases * Execute document and change control process ensuring accuracy and completeness of documents prior to release * Collaborate with other teams in the timely implementation of protocols, reports and other design control and process validation * Guide cross-functional teams in good documentation practices * Review batch records for completeness and accuracy * Support maintenance of design history files, device master records, and technical files * Facilitates document retrieval during regulatory inspections * Support Operations in Inventory part number control and BOM maintenance as a result of an approved request * Support maintaining the Training Program Position Requirements Education and Experience: * Minimum High School Diploma; bachelor's degree preferred * 2-5 years of Quality Assurance Experience * Experience with MasterControl preferred Skills Technical * Proven and effective interpersonal communication skills with a demonstrated ability to interact with internal customers in a positive, friendly, and professional * Excellent presentation skills and writing * Adept at influencing, gaining consensus, and capable of overcoming resistance by presenting a powerful case for implementing new initiatives or * Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment. * Experience working in an FDA regulated environment is * Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents. * Experience with Document and Change Control electronic systems * Experience with Master Control * Experience with ERP systems Skills General * Must be a hands-on, self-directed, detail oriented and conscientious individual * Complete work in a timely, accurate and thorough manner * Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMarks business * Effective analytical problem solving, judgment and decision making skills are required * Strong time management and organizational skills in a dynamic, constantly changing environment * Ability to read, write and analyze complex documents * Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals * Ability to work effectively, exhibit a professional manner and establish constructive working relationships GenMark Dx does not accept agency submittals. Please do not forward resumes to our Executive team, Management team, or any current GenMark employee for review. GenMark Dx is not responsible for any fees related to unsolicited resumes. GenMark is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind: GenMark is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at GenMark are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. GenMark will not tolerate discrimination or harassment based on any of these characteristics. GenMark encourages applicants of all ages. GenMark participates in E-Verify. GenMark is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.