Associate Scientist / Scientist - Analytical R&D

Research and Development/Analytical and Formulary Allegan, Michigan


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

The professional in this role will provide leadership and support to maintain and improve Analytical R&D laboratory systems with an emphasis on supporting laboratory-based software applications.  In addition, this professional will participate in internal and external audits, provide technical review of data and documentation, and serve as a project leader to manage special initiatives and improvement teams.

 

Key Responsibilities:

  • Manage laboratory software lifecycle (select, acquire, develop, validate, deploy, monitor/audit and retire) 
  • Collaborate with IT and QA Validation Departments to facilitate computer system validation activities; developing and/or executing user acceptance tests
  • Provide timely and accurate support for departmental SharePoint sites, Electronic Laboratory Notebook (ELN), Scientific Data Management Systems (SDMS) and other laboratory information applications for internal and external users
  • Explore platforms for data visualization (JMP and Power BI)
  • Develop and implement innovative functionality in applications as required by evolving business needs
  • Participate in and lead improvement projects with an emphasis on improving systems within a continuous improvement framework

 

Other Responsibilities:

  • Represent department for internal and external audits and perform monthly department audits
  • Partner with other groups (on-site and other Perrigo global sites) on special initiatives and teams
  • Create and update best business/compliance practices for efficiency and robustness
  • Contribute subject matter expertise in data governance, data integrity and data analytics
  • Update and maintain documentation associated with ELN and ALIMS (such as Work Instructions, Functional Requirements, Change Control)
  • Create, review, and train department on SOP and departmental Business Process Procedure revisions
  • Attend and actively participate in project and departmental meetings
  • Review regulatory requirements (USP/NF, FDA, ICH, CFR, other compendia) to provide and implement proposed recommendations or requirements

 

Qualifications:  

  • Bachelor’s degree in Chemistry or related sciences with a minimum of 2 years of relevant experience in a cGMP or cGLP laboratory
  • Familiarity with computer systems validation and customizable software applications (such as SharePoint, electronic notebooks, chromatographic data systems, and laboratory information systems) is a plus
  • Excellent written and oral communication skills
  • Strong presentation skills
  • Quality and detail-oriented documentation skills
  • Ability to effectively interact with all levels of the organization to achieve goals and influence decisions
  • Ability to solve complex problems independently and with teams
  • Thorough working knowledge of cGMP, cGLP, FDA regulations, and ICH guidance documents
  • Proficiency in managing multiple projects, prioritization, and organization.

#DIV

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.