IT Administrator- Quality management System

RxCloud$70K — $95K *
US-AnywhereRemote in Oregon, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent experience
  • Minimum 3 years in Quality Management system administration
  • Relevant certification preferred
  • Strong knowledge of various infrastructure solutions
  • Experience with computerized QMS applications

Responsibilities

  • Manage controlled documents in compliance with regulations
  • Collaborate with QA to develop and implement policies
  • Act as secondary eQMS administrator for document control
  • Support training on Quality Systems processes
  • Assist with internal audits and reviews of documents
  • Provide consultation on CAPA processes
  • Recommend process improvements based on quality metrics

Benefits

  • Opportunity to work with cross-functional teams
  • Professional development opportunities
  • Impactful role in quality management and compliance
  • Access to advanced Quality Management technologies
  • Supportive environment for career growth
Full Job Description
IT Administrator- Quality management System Under direction of the QMS Lead Admin and Enterprise Quality Assurance Leadership the Quality Management System Specialist will be responsible for the day to day support and development needs for AmerisourceBergens Quality Management System (QMS). The Quality Systems Specialist will partner with IT to create and maintain QMS processes to meet the needs of QA departments and manage effectiveness and standardization of the QMS across the organization. This includes the capability to document best practices, identify process inefficiencies, and ensure alignment of QA processes with corporate strategy and policy. The Quality Systems Specialist will be responsible for producing reporting, gathering metrics, and intaking business requirements for enhancements, add-ons, and executing on complex process-oriented projects. Other responsibilities include troubleshooting problems as reported by users, supporting Web access to eQMS services and maintaining a secure systems environment. They will also facilitate infrastructure expansion in tandem with the eQMS vendor, based on application needs and anticipated growth andwork with project managers to coordinate and plan project tasks and resources. PRIMARY DUTIES AND RESPONSIBILITIES: • Manage the controlled documents (Policies, SOPs, WIs and Forms) in the eQMS and maintain them in compliance with corporate and/or regulatory requirements. • Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required. May perform the roles of document Author, Reviewer, and/or Approver. • Serve as the secondary (back-up) administrator of the eQMS for controlled documents, assignment of training, profile updates, vault creation, obsolescence of documents, etc. • Support training for Quality Systems processes as needed. • Assist the EQA team with performing internal audits, reviews of controlled documents, etc. as required. • Provide support and consultation on the CAPA process, including the CAPA-intake processes and forms (such as deviations, non-conformances, complaints, audits, etc.). • Follow-up and provide data required for key performance quality metrics related to controlled documents, CAPAs and continuous quality improvements. • Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics. • Maintain status reports for quality systems activities and provide to stakeholders as scheduled/requested. • Support the Business Process Owners (BPOs) in providing technical, procedural, and compliance-based guidance to eQMS users as needed. • Provide support during regulatory inspections by Health Canada and during quality audits by customers and third party auditors. • Provide assistance to the QA Managers and QA Director as required. • Work under challenging deadlines and be accountable for completing work within specified time periods. • Works closely with IT / QA to manage risk, verification, quality, and validation plans. What your background should look like • Bachelors degree or technical institute degree/certificate or equivalent work experience. • Typically requires a minimum of three (3) years of relevant experience deploying and/or administrating Quality Management solutions • Relevant certification is preferred • Requires strong knowledge and experience with multiple infrastructure solutions. MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS: • Ability to work cross functionally to develop and maintain QMS system, documentation, and regulatory requirements • Proficiency in the use of computerized systems to effectively administer the specialized electronic quality management system (eQMS) applications, as well as efficiently utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat). • Strong organization skills • Good analytical and problem solving skills. • Ability to communicate effectively both orally and in writing • Good interpersonal skills; solid team player • Exceptional customer service skills • Good group presentation skills • Ability to lead tech

About RxCloud

RxCloud Careers

Joining RxCloud presents an unparalleled opportunity to become part of a leading team of professionals dedicated to pioneering innovations in the healthcare technology sector. RxCloud is renowned for its commitment to diversity, leadership, and professional growth, making it an ideal workplace for ambitious individuals looking to advance their careers.

Explore Job Opportunities

RxCloud offers a variety of job opportunities that cater to a range of skills and experiences. Whether one is seeking an entry-level position or a more senior role, RxCloud is keen on hiring top talent to join their dynamic team. The company values curiosity, creativity, and solution-driven team players.

Internship Programs

Kickstart a career in healthcare technology with an internship at RxCloud. Internships provide invaluable industry experience and a chance to develop professional skills in a real-world setting. RxCloud’s internship programs are designed to foster innovation and provide hands-on training that prepares interns for future employment.

Professional Growth and Development

RxCloud is committed to the professional growth of its employees. The company offers comprehensive benefits and resources to support career advancement and personal development. From leadership training and workshops to networking events, RxCloud invests in its team members to help them reach their full potential.

Inclusive Culture and Diversity

The culture at RxCloud is built on a foundation of inclusivity and diversity. The company believes that a diverse team leads to better innovation and more effective problem-solving. Diversity training is integral to RxCloud’s ethos, ensuring that all team members feel valued and understood.

Benefits of Working at RxCloud

Employees at RxCloud enjoy a range of benefits designed to enhance their work-life balance and job satisfaction. These benefits include competitive salaries, health insurance, retirement plans, and more. RxCloud recognizes the importance of providing a supportive environment where employees can thrive both professionally and personally.

Applying for a Position

To apply for a position at RxCloud, candidates should prepare their resume to highlight relevant experience and skills. The interview process at RxCloud is designed to assess not only professional qualifications but also a candidate's fit within the company culture and team. Interested candidates can explore open positions and submit their applications through the RxCloud Careers page.

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