Quality Systems Software Architect I- Fully Remote
Company: Aerotek
Location: Raleigh
Posted on: January 12, 2021
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Job Description:
Description:Responsible for quality computer system
administration, providing technical/end user support for quality
computer system(s) The role requires assisting in quality computer
system validation efforts that is executed in compliance with
cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex
11, ICH guidelines, and other applicable industry regulations.---
Provide technical support and system troubleshooting for end
users.--- Provide daily support for end users on system navigation
and business process questions.--- Administer user access, to
include:? on-boarding? off-boarding? access group maintenance?
training environment user access maintenance--- Develop and
maintain a strong partnership with internal departments and quality
users to achieve business and project goals.--- Assist with
maintaining validation documentation deliverables such as URS, FRS,
Configuration Specification (CS), and Requirements Traceability
Matrix (RTM), and system procedures (SOPs) in accordance with cGMP,
21 CFR Part 11, EU Annex 11, and related regulatory requirements to
ensure the system is maintained in a validated state.--- Monitor
and support completion of projects to ensure project deadlines are
met while communicating status accordingly.--- Assist with
implementing quality system training programs, including
development of training materials and training curriculum content
in collaboration with the Training Department.--- Schedule and
provide classroom training as applicable to each system.Able to
react to change productively and handle other essential tasks as
assignedSkills:System Support, quality system, system
administrator, technical support, compliance, Python, JavaScript,
help desk, cross functional teamsAdditional Skills &
Qualifications:--- Bachelor degree (or Associate Degree and
additional related work experience) in pharmaceutical science,
biology, chemistry, or related science/ IT.--- 1 - 2 years of
combined experience in quality computer system support and
administration in the pharmaceutical/biopharmaceutical industry
preferred. Some experience with JavaScript or Python desired.---
Working knowledge of FDA and/or EMEA regulatory
requirements/guidelines as they relate to all aspects of quality
systems and compliance (i.e., 21CFR Part 11, Data Integrity, etc.)
desired.About Aerotek:We know that a company's success starts with
its employees. We also know that an individual's success starts
with the right career opportunity. As a Best of Staffing-- Client
and Talent leader, Aerotek's people-focused approach yields
competitive advantage for our clients and rewarding careers for our
contract employees. Since 1983, Aerotek has grown to become a
leader in recruiting and staffing services. With more than 250
non-franchised offices, Aerotek's 8,000 internal employees serve
more than 300,000 contract employees and 18,000 clients every year.
Aerotek is an Allegis Group company, the global leader in talent
solutions. Learn more at Aerotek.com.The company is an equal
opportunity employer and will consider all applications without
regards to race, sex, age, color, religion, national origin,
veteran status, disability, sexual orientation, gender identity,
genetic information or any characteristic protected by law.
Keywords: Aerotek, Raleigh , Quality Systems Software Architect I- Fully Remote, Other , Raleigh, North Carolina
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