Posted to MedZilla on 3/19/2019


Takeda Pharmaceuticals

US-GA, Senior Quality Control Lab Systems Administrator SR0032673-MZ


 
 

Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Maintain the network of instruments and client systems 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 SOPs, Specifications, FDA, GLP, QSR and cGMP regulations.
Assist in the building and maintenance of custom queries and reports, including but not limited to using Oracle SQL Developer and Crystal 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 SOPs.
Work within the LIMS system in an administrative role, including but limited to user/role management, troubleshooting issues, assisting end users.
Assist analysts in troubleshooting issues via remote connection after business hours as needed and required.
May perform other duties as assigned.

Requirements:

Strong technical problem solving skills in the area of regulated 21 CFR laboratory instrumentation and data integrity.
Knowledge of laboratory instrumentation and software, including but not limited to Empower, LIMS, Chromeleon and OpenLab.
Excellent computer skills, including but not limited to Microsoft Word, Excel PowerPoint and Access. Knowledge of Crystal Reports and SQL Developer a plus.
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 business hours as needed and required.

Qualifications:

Bachelor s Degree in Information Technology or Chemistry or Biological Sciences with 2-5 years experience, or Master s Degree in Chemistry, or Biological Sciences, with 0-3 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

Reasonable Accommodations

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

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.