Quality Assurance Specialist, Global Computerized Systems, Gaithersburg, MD
Our client is seeking a Quality Assurance Specialist for a contract opportunity in Gaithersburg, MD.
- Responsible for planning, coordination, execution and monitoring of quality assurance activities supporting enterprise (global) computerized systems, including infrastructure and software quality.
- As part of a global team charged with the continuous improvement of compliance, efficiency, and effectiveness of GxP business processes, this role works closely with the IT organization to identify and address business needs throughout the software quality lifecycle, from selection through validation, monitoring, migration and retirement.
- The Specialist serves as System Administrator for multiple enterprise IT systems, primarily Laboratory Information Management (LIMS) and Chromatography Data Acquisition (CDS) systems.
- In addition, this role facilitates performance to milestones of multiple cross-functional teams through effective decision-making, assessing the adequacy of change plans and validation protocols, and maintaining timely and open communication with key stakeholders.
- Serve as global quality approver of IT-related enterprise change requests and validation documents, including protocols, test scripts and reports.
- Manage configuration changes, access and segregation of duties in global GxP IT systems.
- Verify availability and adequacy of enterprise GxP software training and procedures.
- Provide guidance on project teams to best ensure compliant, efficient and effective outcomes.
- Interpret and apply current Good Manufacturing, Clinical, Distribution and Laboratory practices to the continuous improvement of business processes and procedures reflected in computerized systems.
- Work with the IT organization to identify and implement enabling technology solutions for the business.
- Perform gap assessments and audits of data integrity and computer system validations.
- Provide routine budgetary updates and variance explanations against approved budgets.
- Bachelor’s Degree in biological or computer science.
- Minimum of 5 years of pharmaceutical and / or medical device experience with specific experience applying 21 CFR Part 11 and EU Annex 11 requirements, along with broad working knowledge of other GxP and ISO regulations and guidance.
- Experience with electronic document management, non-conformance, CAPA, and change control systems.
- Knowledge of Laboratory Information Management (LIMS) and Chromatography Data Acquisition (CDS) systems.
- Excellent written and verbal communication skills.
- Ability to prepare reports and presentations for executive management and other audiences with a demonstrated ability to clearly communicate complex information.
- Ability to critically evaluate data summaries and conclusions.
- Proficiency in industry standard software applications such as MS Office products or comparable word-processing and spreadsheet skills.
- Only those individuals selected for an interview will be contacted.
- No calls, inquiries, or Third Party Vendors please.
- We are an equal opportunity employer (Unable to sponsor H1B Visas).
Since 1988, The ACI Group, a Baltimore-based IT staffing firm, has been committed to hiring the industry’s leading professionals, and presenting exciting career opportunities. We have access to varied types of contract, permanent and contract-to-perm positions and offer a choice of employment options including a full benefits package.