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QC Lab Systems Administrator

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **www.astellas.com** .

The Role

The **Technical BioPharma Manufacturing QC Systems Administrator SFD-TC** will be responsible for providing System Administration support for the QC lab systems. This role will support the ongoing operations and maintenance lifecycle of QC instruments as the primary contact for System Administration and first line technical troubleshooting on lab instruments. The role will follow site and department procedures/SOPs, perform routine tasks and troubleshooting independently, and perform non-routine tasks and small projects with oversight as needed. The role will work collaboratively with the lab equipment System Owners, Business Owners, and users as well as Validation, IT, and Quality functions.

+ Support and maintain QC Lab systems and equipment as the system administrator.

+ Collaborate with cross-functional groups (QA, Validation, IT, etc.) to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment

+ Maintain system configuration documents and administration SOPs

+ Author, execute, and/or review test plans and review IQ/OQ protocols as needed

+ Perform first line troubleshooting for QC Lab Systems (e.g., user access issues, Windows issues, communication issues)

+ Collaborate with vendors and other support teams (Automation, IT/IS, etc.) for advanced troubleshooting and configuration

+ Perform business administration activities for other QC Lab software such as the Empower chromatography system and the LabX system which supports lab instruments like balances, pH meters and conductivity meters

+ Support both internal and external audits as needed

+ Own and manage change controls, non-conformances, and CAPAs for QC lab computer systems, as needed

+ Troubleshoot issues, solve problems, and assist with investigations and deviations

+ Ensures lab systems are compliant with Astellas Policies and SOPs and applicable regulations (e.g., 21 CFR part 11)

Required Qualifications

+ B.S. degree in IT, computer systems, or related field with 5+ years, M.S. degree with 3+ years, or Associate degree with 8+ years of relevant experience in working with analytical computerized systems. Comparable combinations of education and/or experience may be considered.

+ Direct experience as a System Administrator for QC Laboratory computer systems in cGMP/GLP settings. Includes experience with configuring and testing systems.

+ Experience with Windows OS, domains, networks and basic computing infrastructure in lab environment. Includes commercial-off-the-shelf (COTS) lab computer systems.

+ Experience with regulations governing data integrity and computerized systems

+ Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment

+ Comfortable working in a GxP environment, SOPs and quality control processes

+ Handles multiple tasks concurrently to deliver quality results in a timely fashion

+ Works closely with team and other functional key to execute work and will be expected to perform other duties and/or special projects as assigned

Preferred Qualifications

+ Experience in translating laboratory user requirements to IT implementations

+ Experience in qualification of analytical equipment, including those with computerized systems

+ Experience conducting data integrity (DI) assessments and the associated DI remediation activities

+ Experience serving as a change agent and driving continuous improvement and automation across QC

+ Good to excellent technical writing skills and verbal communication skills

+ At least 2 years of direct experience as a System Administrator for QC Laboratory computer systems in cGMP/GLP settings

Working Environment:

+ This position is based in Sanford, NC and will require on-site work

+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs

+ This position may be required to occasionally work during non-traditional work hours and to participate in an on-call rotation for support calls

+ On occasion, this role may travel to other Astellas manufacturing facilities (0-5%)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Referral bonus program

_Flexible grade level based on candidate background and skillset_

_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._

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Category Sanford TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans