Quality Assurance Specialist

Job Info

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.

Your Role:

As a member of the Quality Systems team, you will be responsible for facilitating document workflows in MilliporeSigma's electronic document management system ensuring documents go through controlled document life cycle in accordance to established procedures. In this role you will effectively work with internal colleagues, external contractors, independently manage timelines, and work consistently to ensure documents are within the prescribed guidelines. This role will work successfully in a fast-paced environment, changing priorities to support internal departments and communications. This role will interface closely with other cross-functional groups such as Validation, Engineering, QC, Quality, Facility, and Manufacturing.

  • Ensure documents meet formatting and template requirements, adhere to required review and approval requirements and project timelines
  • Perform formatting of documents, as needed
  • Perform documentation coordinator activities in eDMS and work with departments on documentation needs
  • Author or revise standard operating procedures related to Quality System's document control, as needed
  • Provide documentation support during client audits, regulatory inspections, and internal audits
  • Assists with the improvement of quality compliance by recognizing continuing issues and bringing them to management's attention
  • Support compilation of department metrics and report out to management, as needed
  • Support onsite and offsite archival and tracking of records
  • Other job duties and projects as assigned
  • Off-shift, weekend, and overtime duties may be assigned to support project timelines

Physical Attribute:
  • Sitting and reaching to use computers and other office equipment
  • Employee works in a professional office environment with computer equipment

Who you are:

Basic Qualifications:
  • Associates Degree in a Scientific Discipline or 3+ years of experience in a cGMP environment.
  • 3+ years of document management activities.
  • 3+ years of experience in writing GMP standard operating procedure.

Preferred Qualifications:
  • Experience managing quality-controlled documents, internal records, revision workflows and document change control processes required
  • Proficient computer skills in usage of MS Office Suite (Word, Excel, Power Point), Visio, Adobe
  • Excellent written and verbal communication skills and interpersonal relationship skills
  • Excellent problem-solving and critical thinking skills
  • Strict attention to detail
  • Ability to manage competing priorities in a fast-paced environment and maintain a sense of urgency
  • Adhere to compliance with internal procedures
  • Proactive, enthusiastic, and fastidious learner able to adapt to changes and provide sound decision-making
  • Ability to interact professionally with all organizational levels

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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.

Job Requisition ID: 218410

Location: Carlsbad

Career Level: C - Professional (1-3 years)

Working time model: full-time

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