System Administrator - GMP Laboratory
Company: Pace Analytical Services, LLC
Location: Saint Paul
Posted on: August 6, 2022
Job Description:
Summary:
The System Administrator - GMP Laboratory is responsible for
participating in systems related to generation of GMP documents and
records for FDA regulated environment. Responsibilities will
involve interacting with vendors and local IT support functions to
configure, install, qualify, and validate the systems, assist with
installing and qualifying network IT systems such as physical and
virtual servers, as well as installing and validating laboratory IT
systems such as ELN, EDMS, LIMS, and other various lab software.
The role will also be responsible for monitoring, execution,
maintenance, and continuous improvement of the IT Systems with an
emphasis on change control, validation/qualification, continuous
improvement, especially in regard to data integrity. This role will
serve a business representative for laboratory IT systems and will
be responsible for mentoring, educating peers on the use of lab
systems, supporting audits.Essential Functions:
This class specification lists the major duties and requirements of
the job and is not all-inclusive. Incumbent(s) may be expected to
perform job-related duties other than those contained in this
document and may be required to have specific job-related knowledge
and skills.
- Participate in GMP validation activities including the
execution of IQ/OQ/PQ testing; assist with creation of test scripts
as required. Perform integration and system level tests and execute
any necessary supporting documentation.
- Support the establishment and maintenance of the validated
state of software-based computerized systems in use in the
laboratory.
- Apply cGMP principles by following internal SOPs and regulatory
requirements.
- Help lead site deployment and upgrades of Laboratory IT systems
such as Empower, UNIFI, MassHunter, ELN, and LIMS.
- Help to maintain and administer internal Life Sciences Help
Desk, Internal Life Sciences Network, network backups, and Active
Directory (including group policies).
- Provide oversight and support continuous improvement of quality
systems as they relate to the laboratory.
- Apply knowledge of quality principles, CGMP, and laboratory
systems towards the development and execution of local procedures
and practices.
- Perform and mentor others in change control,
deviations/modifications, investigations, root cause, and activity
planning.
- Participate in Server (VMware, virtual and physical) setup
(inventory, qualification, changes, maintenance, repairs).
- Provide support during systems implementation and configuration
to ensure the solutions will meet business needs while adhering to
IT and Quality policies and procedures and compliance
standards.
- Diagnose, troubleshoot, and resolve hardware, software, or
other network and system problems, and replace defective components
when necessary.
- Assist in the qualification of internal networks.
- Contribute to the efficiency and effectiveness of the
department's service to its customers by offering suggestions and
directing or participating as an active member of a work team
- Promote and support the overall mission of Pace Analytical by
demonstrating courteous and cooperative behavior when interacting
with customers and staff; acts in a manner that promotes a
harmonious and effective workplace environment.
Qualifications:To perform this job successfully, an individual must
be able to perform each essential duty satisfactorily. The
requirements listed below are representative of the knowledge,
skill, and/or ability required.
Education and Experience:
Bachelor's Degree with 1 years of relevant experience or
equivalent.Or Associate degree with 3 years of relevant experience
or equivalent.
Preferred Knowledge and Skills
Preferred Knowledge:
- Microsoft Active Directory
- Server/VMware/Virtualization
- Data backup and restore
- Microsoft operating systems and software installation and
maintenance, including servers and workstations
- Standard personal computer system hardware and business
application software operating capabilities and limitations
- Knowledge of managing and configuring Switch/Routers/Wi-Fi
access points
- Understanding of GAMP 5, 21 CFR Part 11 and Computer System
Validation / Computer Software Assurance
- Experience administrating LIMS (Preferred not required).
- Ability to communicate with staff, coworkers, and customers to
ensure safe, effective, and appropriate operations.
Preferred Skills:
- Maintaining accurate records of work performed.
- Preparing clear and concise documentation, user instructions,
reports, correspondence, and other written materials.
- Working without close supervision in standard work
situations.
- Multi-tasking between project and event driven work.
- Using initiative and independent judgment within established
procedural guidelines.
- Contributing effectively to the accomplishment of team or work
unit goals, objectives, and activities.
- Establishing and maintaining effective working relationships
with a variety of individuals contacted in the course of the
work.Physical/Mental Requirements:The physical demands described
herein are representative of those that must be met by an employee
to successfully perform the essential functions of the job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.Mobility to work in
an office setting, use standard office equipment and
ability/stamina to stand/sit for extended periods of time; ability
to wear appropriate PPE; ability to lift/push/pull/carry up to 40
pounds; ability to crouch/bend/twist/reach; must be able to perform
activities with repetitive motions; vision to read printed
materials and computer screens for extended periods of time; and
hearing and speech to communicate in person or over the
telephone.
Working Environment:Work is performed in an office/laboratory
setting. Work may be subject to exposure to electrical shocks and
chemicals.OFCCP Statement Pace Analytical is an Equal Opportunity
Employer and will not discriminate against any applicant for
employment on the basis of race, age, religion, sex, veterans, and
individuals with disabilities, sexual orientation, or gender
identity.
#STAR
Monday through Friday first shift hours. Time to time request to
come in early, stay late, and occasional weekend work as
needed.
Keywords: Pace Analytical Services, LLC, St. Paul , System Administrator - GMP Laboratory, Healthcare , Saint Paul, Minnesota
Didn't find what you're looking for? Search again!
Loading more jobs...