Senior Quality Systems Administrator

4 weeks ago

St Louis, Missouri, United States Mallinckrodt Pharmaceuticals Full time
Job Title

Sr Quality Systems Admin



Job Description Summary

The Sr. Quality Systems Admin provides support to LIMS, Chromeleon, LES, and other laboratory systems across multiple sites. Develops solutions to routine technical problems of moderate scope. Leads site projects and participates as a team member for corporate system projects. Reviews higher-level decisions for soundness of technical judgment and overall adequacy and accuracy with more senior team members or management.



Key Responsibilities
  1. Responsible for site system administration, user support, issue resolution and training related to the use of LV LIMS, Chromeleon CDS, BioVia LES, and other laboratory computer systems
  2. Write, update, and obsolete procedures related to Chromeleon and laboratory chromatography data, LIMS, and LES
  3. Creation of new product test procedures based on approved laboratory methods and SOPs
  4. Installation and interface with new equipment
  5. Design and implement maintainable configurations, extensions, and customizations
  6. Develop and execute test scripts, create user manuals and other training material
  7. Support ad-hoc and custom reporting
  8. Participate as a team member delivering on approved projects
  9. Ensure that all activities adhere to relevant policies, SOPs, and regulations
  10. Work collaboratively across the organization, project team and with other groups as needed to ensure projects and support activities are executed successfully
  11. Participate in periodic review and disaster recovery programs for computerized systems
  12. Provide general technical support to IT departments as required
  13. Part of a team that provides 24/7 on-call support
  14. Adhere to all safety rules and maintain 100% completion of all safety required training


Requirements
  1. BS or BA in Life Sciences, Engineering, Computer Science, related technical field or equivalent combination of education, experience, and competencies
  2. A minimum of five years of relevant experience in the pharmaceutical or similarly regulated industry is required. Experience with laboratory computer systems required and preferably as an administrator, especially LabVantage LIMS, Chromeleon CDS, or BioVia LES


Preferred Skills
  1. Self-motivated, demonstrates initiative
  2. Ability to write documents in a clear, concise manner
  3. Independence and sound decision making capabilities
  4. Excellent communication and customer service skills are required to provide clear instructions or information when working with clients, consultants, peers and others in the company
  5. Possess sufficient interpersonal skills to be able to function as part of a team
  6. Attention to detail and accuracy
  7. Experience programming with SQL, PL/SQL


Organizational Relationship/Scope

Reports to Sr. Quality Manager

Works under limited supervision.

Follow established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.

Primarily internal company contacts with frequent inter-departmental contact on routine matters. Contacts include Information Technology, Quality Control, Quality Assurance, R&D, Corporate Quality and Regulatory, Manufacturing, and Logistics.

Contributes to the completion of milestones associated with specific projects and maintaining existing systems. Failure to achieve results or erroneous decisions or recommendations may cause delays in production or schedules and may impact Quality and Service.



Working Conditions

90% Office environment which includes sitting for long periods of time and computer use.

10% Laboratory and Plant environment exposure to temperature, noise, chemical or products.

Occasional Travel is required for projects, training and site support



Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.

They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives.

Our dynamic work environment provides unique experiences for employees to grow and develop.

Invest in your own career with Mallinckrodt and let's do something dynamic together.

Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

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