Operations Associate Scientist / Scientist

Perrigo Company Corporate Allegan , MI 49010

Posted 2 months ago

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, lead internal and external laboratory audits, provide technical review of data and documentation, and serve as a project leader to manage special initiatives and improvement teams.

Other Key Responsibilities:

  • Participate in and lead improvement projects with an emphasis improving systems within a continuous improvement framework.

  • Represent department for internal and external 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

  • Lead process harmonization initiatives to support successful analytical technology transfers with other Perrigo sites, Quality & in-license partners

  • Review metrology and stability data, perform stability study administration, and assist in implementation of new laboratory equipment

  • Develop and maintain departmental metrics and capacity models

  • 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

  • Develop and implement innovative functionality in applications as required by evolving business need

  • Collaborate with IT and QA Validation Departments to facilitate computer system validation activities; developing and/or executing test scripts as required

  • 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 3 years of relevant experience in a cGMP or cGLP laboratory

  • Excellent computer, 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.

  • Familiarity with computer systems validation and customizable software applications (such as SharePoint, electronic notebooks, chromatographic data systems, 3and laboratory information systems) is a plus

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Assistant Scientist Ar&D

Perrigo Company Corporate

Posted 2 months ago

VIEW JOBS 4/21/2020 12:00:00 AM 2020-07-20T00:00 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 Assistant Scientist will provide technical support to product/process development and commercialization projects which meet the company's Product Branded initiatives or first-to-file strategy and first-to-market company goals; ensure compliance with regulatory standards and the company's procedures. Key Responsibilities: * Provides technical and physical support to product/process development and commercialization activities for new products and modified existing products. Supports the manufacture of new products in product/process development areas and manufacturing facilities. * Generate accurate data, following established procedures and practices. Record, tabulate, summarize and report results to senior scientific staff. Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches. * Execute stability studies as directed. Perform scientific experimentation testing new products in development. Contribute to the development and documentation of new experimental approaches. * With guidance, supports effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects. * Communicates effectively to senior scientific staff and the wider development team and presents data at team meetings and departmental technical meetings. * Ensure compliance with current Drug Enforcement Administration (DEA), current Environmental Protection Agency (EPA) requirements, current FDA/CVM requirements, current Good Manufacturing Practices (cGMP), Perrigo policies and Quality Systems, and all applicable regulatory agencies as applicable to area of project development and work. Qualifications: * Bachelor's degree or higher in an applicable field is required * Some experience in a similar role is strongly preferred Perrigo Company Corporate Allegan MI

Operations Associate Scientist / Scientist

Perrigo Company Corporate