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Quality Assurance Document Control Specialist
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.
The Documentation Specialist will utilize their experience in organizational, data processing, computer, and document review areas to ensure that all data and documentation is handled in a manner for easy retrieval, control and utilization.
This position will govern the interface between site department users and the electronic document management system (ManGo). Additional duties include support of all aspects of Quality Assurance functions associated with document coordination, record coordination and control, data entry and reports, and general office support.
- Review/approve workflows in the electronic document management system(s).
- Provide guidance to system users on change request generation and document formatting.
- Facilitate review and revision of quality documents for periodical review.
- Review open change requests to flag aging requests, errors in generation and communicate to originator actions needed.
- Assist in the creation of draft documents required for electronic document management system.
- Issue manufacturing, packaging and labeling records to production.
- Enter data for quality training and or general office support.
- Organize and coordinate documents and labels to be issued to production based upon standard operating procedures and established production schedule and timelines.
- Complete documentation of activities per Good Documentation Practices.
- Enter data into appropriate databases/spreadsheets for tracking and trending purposes.
- Participate in process improvement activities to include team participation, data collection and general support.
- Provide other assistance as required to maintain integrity of document management, data entry and record control.
- Ensure quality documents reviewed accurately reflect current procedure.
- Initiate workflows and approve documents as required to ensure current procedures are maintained.
- Assist with recalls and field corrections as needed.
- Follow quality procedures when review indicates any deviation from current procedure.
- Utilize system of quality documents for tracking and maintaining control of all documentation.
- Properly issue and review labels and other quality documentation to change status of materials.
- Successfully complete quality training.
- Record quality observations in databases as directed by supervisor to aid in quality improvement efforts.
Who you are:
- HS Diploma or GED Equivalent with 2+ years of administrative support or documentation control experience in the Pharmaceutical, Medical, GMP Manufacturing, or Life Sciences industry
- Working knowledge of cGMP and ISO quality systems
- Extensive document review and attention to detail skills
- Computer skills including proficiency in Word and Excel
- Strong time management and multi-tasking abilities
- Good verbal and written communication skills
- Independent, works well with direction
- Logical approach for understanding systems and problem-solving
- Excellent teamwork and cooperation skills
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.