Document Control Specialist - Quality Systems (Whiptail)

Posté 20 janv. 2022

Carlsbad, California - United States

Demander un identifiant 233725

Détails

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


We are offering a $7,500 sign-on bonus for those that qualify!

 

Your Role:

As a member of the Document Control Quality team, you will support various functional departments with documentation needs to ensure compliance to Regulatory and ISO requirements. You will be responsible for the management of controlled documents internally, document archival for on-site and off-site storage, and facilitating workflows within the site’s electronic document management system. This role supporting daily operations at the Whiptail facility will entail operating in a fast-paced, dynamic environment in collaboration with other departments as well as external stakeholders. You will be the on-site support contact representing Document Control. You will also work independently within the prescribed guidelines and collaboratively as part of a team to meet deadlines and maximize productivity. Off-shift, weekend, and overtime duties may be assigned by the Manager of the employee.

  • Issue/Facilitate Batch Record routing with client and internal communication and approvals for effectivity
  • Pull weekly reporting on effective documents to making copies to update SOP binders
  • Formatting of documents to internal requirements
  • Processing of documents in Electronic Document Management System to support updates and facilitate workflows
  • Fulfilling document requests to functional departments
  • Performing interval review of department logs and spreadsheets per defined requirements
  • Managing on-site and off-site archival for filing/indexing/scanning and request needs
  • Support Regulatory/Client audits as needed
  • Creating logbooks and workbooks upon request by departments
  • Other duties of support may be assigned

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in any science discipline
  • 3+ years of experience in Biologics, Biotech, Pharmaceuticals or Medical Devices.
  • 3+ years of experience working within Quality System processes in a cGMP environment
  • 3+ years of experience in document management

 

Preferred Qualifications:

  • Strong understanding of Quality Systems documentation, and document hierarchies
  • Electronic Document Management System experience
  • Experience and understanding of Quality Systems processes
  • Experience with Microsoft Office Suites (Word, Excel, PowerPoint)
  • Strong attention to detail
  • Experience with formatting documents
  • Professional and effective communication skills, both oral and written
  • Able to work well with other levels and departments within the company, individually, and as part of a team
  • Self-starter and able to perform with minimal supervision

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture.  You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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