Reference # : 20-00844 Title : Quality Assurance Manager, Enterprise Computer Systems Location : Gaithersburg, MD Position Type : Direct Placement Experience Level : Start Date : 10/09/2020 Description Fulltime Position Available
Responsibilities include but are not limited to:
Manage the QA Enterprise Computer Systems group supporting expanding enterprise computer applications, including the review and approval of CSV User Requirements, Functional Specification and CSV protocols, as necessary.
Provide CSV engineer's guidance on best practices for compliant, risk based methods and implementation of enterprise computer systems, including data migration.
Function as the QA SME for enterprise solutions processes providing feedback to the various QA groups as to how various electronic solutions work, specifically SAP.
Function as the QA SME for data integrity best practices and compliance.
Maintain the QA procedures related to CSV review and approval, including writing detailed procedures (SOPs), as necessary.
Collaborate with relevant stakeholders to ensure all aspects of various enterprise computer solutions are included in CSV Program.
Supervise individual contributors, often involving frequent interaction, to provide work direction and resolve problems.
Participate in cross-functional meetings to support the implementation of enterprise computer systems.
Evaluate change controls to determine impact of proposed computer system changes on compliance.
Investigation, review, and approve CSV discrepancies found during the execution of protocols, as well as, other atypical events, deviations, and non-conformances as required.
BS degree in a technical discipline (Computer Sciences preferred, Engineering, Chemistry, Microbiology, or Biology).
Four to six years of CSV experience, with a strong understanding of global enterprise electronic solutions.
Two to three years management experience.
Experience with SAP, LV LIMS, Blue Mountain, laboratory analytical and PV Human Pharmacovigilance electronic systems a plus.
Demonstrated understanding of and experience working in a regulated environment specifically cGMPs.
Strong understanding of data integrity requirements and how to perform assessments.
Experience and demonstrated skills leading teams.
Proven project manager with comprehensive planning ability.
Proven technical expertise in area(s) required.
Travel to other sites may be required.
RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
RCMTechnologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.
Posting ID: 579338972Posted: 2020-10-21