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Job Title: eQMS System Administrator

Department: Quality

Hours Per Week: 40

Schedule: Monday - Friday, 9:00 AM - 5:00 PM

SUMMARY

As an eQMS System Administrator for ACM Global Laboratories, the eQMS System Administrator is responsible for the development, implementation and ongoing continuous improvement of the company’s electronic Quality Systems. In addition the eQMS System Administrator will interface with the business and functional leaders in Quality, Information Technology and Computer System Validation and other stakeholders to promote and support compliance.

RESPONSIBILITIES

+ Serve as a resource promoting the development of understanding of the key elements related to electronic Quality Management Systems & regulatory compliance requirements including training opportunities to all staff at an organizational wide level

+ Manage the promotion and assess the compliance with regulations, guidelines, policies and Standard Operating Procedures within the organization as it relates to the eQMS

+ Provide support and key input to development groups for consultation & interpretation of regulations, guidelines, corporate standards & policies

+ Provide training support of electronic document control system related updates or features to global ACM users.

+ Work independently or with small teams to manage routine eQMS activities.

+ Serve as subject matter expert of eQMS

+ Identify and lead (as assigned) process improvements and initiatives to improve efficiency and effectiveness of eQMS

+ Monitor, track and trend performance of processes within eQMS

+ Recognize opportunities for improvements related to project objectives and apply sound judgement when addressing the issues.

+ Independently generates solutions based on analytical skills and business knowledge.

+ Support and is accountable for projects/programs that involve multi-functional teams.

+ Provide systematic troubleshooting of failed processes or system software and/or technical issues reported by users; be able to quickly diagnose a problem and determine how best it can be fixed in the shortest amount of time with minimal disruption to users.

+ Work with Business Owners to determine and recommend approach when eQMS system requires a software upgrade

+ Collaborate with Business Owners to ensure upgrade programs/applications will match current hardware/software devices and meet business needs.

+ Coordinate beta testing and system upgrades with Business Owners and EQMS.

+ Evaluate system requirements (eQMS or computer needs) to determine potential enhancements or improvements to applications.

+ Make provisions for planned IT maintenance outages; notify user community of system downtime; and provide coverage to IT maintenance team for eQMS system verification to allow for a system restart.

+ Detailed conceptual knowledge/understanding of eQMS system operations and the planning for and responding to service outages and IT maintenance work.

+ Evaluate and implement workflow and system changes per requests from Business Owners

+ Manage system user profiles, permissions and roles in accordance with company policies

+ Utilize the change control system to support quality, consistency, and to protect the integrity of controlled documents, and perform periodic assessments of user access as required by standard operating procedures and regulatory standards and guidelines.

+ Perform other duties as assigned

REQUIRED QUALIFICATIONS

+ 2 years experience with system administration of MasterControl in a GxP environment.

+ Bachelor’s Degree and 1 Year of experience in a laboratory, pharmaceutical, medical device or clinical research organization OR 4 Years’ experience in a laboratory, pharmaceutical, medical device or clinical research organization.

PREFERRED QUALIFICATIONS

+ Effective written and oral communication, technical writing and editing skills.

+ Knowledge of and demonstrated experience in Quality, GCP, ISO15189, Proficiency Testing, CAP, CLIA, GLP.

+ Experience working in and or managing an eQMS or eLMS system.

EDUCATION:

LICENSES / CERTIFICATIONS:

PHYSICAL REQUIREMENTS:

S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

$62,000.00 - $70,000.00

CITY:

Rochester

POSTAL CODE:

14624

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.