Change AnalystNewark, DE, United StatesThere has never been a more exciting time to join us. Our Innovation Center in Newark, DE is expanding and growing! Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. Hologic is seeking Change Analyst to support us onsite in Newark, DE. Apply today!What To Expect:You will be expected to review and process of change orders supporting the quality management system including engineering and marketing literature changes. You will be expected to facilitate and coordinate the interaction between multiple cross functional groups to ensure appropriate changes are documented. You will provides Document Control guidance, support, and troubleshooting to the user community as needed.What We Expect:
Reviews, routes and releases Quality system related documents, parts, and change orders according to established policies and procedures.
Communicate efficiently and effectively with project teams, management and various cross-functional contacts on change order progress.
Manage the storage of quality system related documentation, as appropriate, per established schedules. Ensures Quality System related documents are maintained in a secure and organized manner and ensures documentation is retrievable and accurate.
Interface with appropriate cross functional contacts to expedite activities and support business needs.
Create and provide training on change management processes, including Agile, to support cross functional teams.
Supports development and executes to key performance indicator metrics for documentation control, change management and other Quality System elements including preparation and distribution of reports as needed to drive action and continuous improvement
Provides support and documentation to support internal and external audits.
Assists with providing resolution and/or addressing root cause of issues related to document control.
Supports Document Control projects and initiatives, as necessary.
Monitors and tracks the review, approval, and distribution of documents to ensure timely completion to meet established timelines.
Qualifications:Education:
Preferred Minimum Non-Technical Degree: College Degree
Preferred Minimum Technical/Advanced Degree: Master’s Degree
Qualifications:Education:
Bachelor’s Degree in Engineering, Technology, Document Management preferred or an equivalent combination of education and experience
Experience:
3-5 years’ experience in document control in an FDA regulated environment
Medical Device or Pharmaceutical industry preferred
Understanding of change control regulations as well as ISO and FDA requirements
Skills:
Excels in the use of quality data management tools such as Agile.
Strong computer skills with a working knowledge of Microsoft Office suite
Strong attention to detail and excellent organization skills
English Language: Knowledge of the meaning, spelling, and use of the English language.
Working Knowledge Agile application preferred.
So why join Hologic?We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!The annualized base salary range for this role is $52,400 - $81,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.LI-#DS1
