Description Overview
- This position is responsible for the timely and accurate management of Perrigo documentation and data including document change orders, manufacturing documentation, engineering drawings, BOMs, parts lists, specifications, and any other data, documents, or records that are created and maintained as part of a product’s life cycle. Activities will be performed in the Perrigo document control and / or ERP systems. Additional duties include support of internal, external, and 3rd party audits, DMR and DHF maintenance, Learning Management System input, development and maintenance of quality metrics and continuous improvement activities.
Please note - This is an hourly role working Monday - Friday on first shift
Scope of the Role
Helps to ensure compliance with the FDA's Quality System Regulation as it pertains to documentation and document control and distribution.Ensures that documentation meets established quality standards and deadlines.Collaborates with Change Order Initiators to ensure the accuracy of the change orders.Interacts with various Company personnel and vendors to coordinate and process documentation for both new products and revisions to existing products.Processes, distributes, and maintains copies of released documents, including change orders, Work-In-Process, and Temporary Deviations.Processes approved Change Orders, and coordinates actions required for their completion.Transmits specifications to approved suppliers where indicated.Inputs information into the ERP system when necessary.Reviews engineering documentation.Pushes out training to required trainees in the LMS system.Provides direct support during regulatory audits.Maintains current documents in SharePoint document repository.Maintains document control tracking databases and the Master Document Register.Proactively seeks methods to reduce cycle times in all areas of responsibility on a continuing basis.Performs special projects and support functions as assigned by the Global Configuration Assurance Manager.Responsible for information entry into SharePoint and the documentation system.Protects and preserves current master documents and historical files.Responsible for maintaining files for engineering drawings, project reports, SOPs, specifications, and other various controlled documents.Support effective implementation of all GMP requirements and understand how it affect products / processes supported and / or owned.Experience Required
Associate degree preferred. Experience will be considered in place of formal education.Document Control experience in medical device, pharmaceutical, or other regulated industry.Strong understanding of FDA and ISO Standards. Must be capable of ensuring compliance to the regulations applicable to controlled documentation.Demonstrated ability to complete assignments of increasing complexityStrong understanding and working knowledge of computer databases and systemsProficient in SharePoint.Proficient in MS Word, Excel, Visio, Adobe Pro, PowerPoint.Must be a self-starter. This position has maximum responsibilities with minimum supervision (when any necessary training is completed).Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more Applicants please note : To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo
