US-GA, Quality Control Lab Systems Administrator SR0039671-MZ
Maintain the network of instruments and client systems, primarily Waters Empower software, per 21 CFR requirements, including but not limited to account management, troubleshooting, training, security, group policies and instrument lifecycle.
Maintain data integrity, including but not limited to performing assessments, backup and recovery, periodic reviews and disaster recovery per FDA guidelines and company SOP's.
Write and execute IOQ's, PQ's and related documentation for new instrumentation and re-qualification as required for existing instruments according to laboratory needs.
Stay current in the field of laboratory instrumentation and data integrity to ensure compliance with company SOP's, FDA, GLP, QSR and cGxP regulations.
Assist in the maintenance of reports for departmental indicators, trending and charting.
Follow continuous improvement practices, including but not limited to QLP, 5S, LEAN, etc.
Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
Perform laboratory instrumentation audits as required. Review and update, as required, software administration SOP's.
Assist analysts in troubleshooting issues via remote connection after business hours as needed and required.
May perform other duties as assigned.
At least 2 years experience in laboratory software administration, including but not limited to Empower Enterprise Systems.
Strong technical problem solving skills in the area of regulated 21 CFR laboratory instrumentation and data integrity.
Excellent computer skills, including but not limited to Microsoft Word, Excel, Power Point and Access.
Must be able to read and follow detailed written instructions and have good verbal/written communication skills with supervisors, peers, vendors and technical support.
Ability to handle multiple tasks concurrently and in a timely fashion.
Must Demonstrate effectiveness in ability to train others.
Availability to the laboratory network via remote connection after normal business hours as needed and required.
Bachelor's Degree in Chemistry/Biological Sciences or Information Technology with 2-5 years experience.
Appropriate additional certifications may be required pursuant to state or federal regulatory requirements.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Please visit our website at takedajobs.com