Prospanica 2016 Senior Process Informatics Technology Associate

Prospanica 2016 Senior Process Informatics Technology Associate
+ Requisition ID:141784
+ Position:
+ Open date:Aug 24, 2016 9:33 PM
+ Functional area:Technical
+ Location:Maryland
+
+
+ + Required degrees:Bachelors
+ Experience required:2 years
+ Relocation:No
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Basic qualifications:B.S. degree in Computer science, mathematics, engineering, biology, statistics, or other related fields.
2+ years experience in the application of data management and other informatics systems.
Preferred qualifications:? Knowledge of database design, operation and maintenance.
? Experience with manufacturing priorities and use cases for data reporting, and their context/requirements within a regulated industry.
? Basic knowledge of Biopharmaceutical manufacturing processes, methods, and equipment
? Experience with insuring databases meet GMP and 21 CFR Part 11 guidelines.
? Demonstrated project management and communication/documentation experience
? Quantitative and problem solving experience.
? Demonstrated ability to work as part of a cross-functional team.
? Able to prioritize multiple competing priorities.
Details:Why GSK? Because GSK?s Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK?s Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance ? Being accountable for quality and safety.
GSK Rockville has an opening for a Senior Process Informatics Technology Associate. The primary purpose of the Sr. Process Informatics Technology Associate role is to manage information from the manufacturing process, product quality, and other related information sources to empower stakeholders with data & informatics solutions, and to support their use. The role is responsible for technical leadership in identifying data-related needs and devising solutions. Person in this role will be responsible for engaging with stakeholders to understand their business requirements, and to design/deliver the data entry, data access, and reporting solutions fit for their intended uses.
Key Responsibilities:
? Responsible for database design including determination of data sources, structure, data entry, data query and reporting.
? Identifies requirements to ensure databases meet appropriate regulatory compliance (GMP) requirements.
? Responsible for change control for relevant GMP data
? Responsible for training personnel that work with the databases for data entry and data queries.
? Responsible for daily operation and maintenance of informatics systems and databases
? Responsible for investigation and mitigation of informatics systems availability and configuration issues.
? Provides strategy to combine and relate data from a variety of data sources, including databases or other relevant sources. Organize and present data in a format which provides useful knowledge to end users.
? Responsible for ad-hoc data analysis to support process investigations.
LI-GSK
Contact information:
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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