Remote or Hybrid Quality Systems Specialist

Job Title: Quality Systems Specialist (Contract)

Location: Remote (Preference for candidates local to Cambridge, MA, for occasional onsite support)

Work Schedule: Monday - Friday, 40 hours per week

Typical Hours: 8:00 AM - 4:30 PM EST (latest start time 8:30 AM EST)

We are seeking a highly organized and detail-oriented Quality Systems Specialist to support change control and regulatory intelligence processes within a leading pharmaceutical/biotech company. This is a contract role with a remote work arrangement, but candidates local to Cambridge, MA, are preferred to accommodate onsite needs as they arise. The role is open to candidates in any U.S. time zone.

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  Manage and analyze change control processes, providing updates and serving as the right-hand support for analysis.

  
  
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  Conduct regulatory intelligence activities, including managing alerts, assessing potential impacts, and distributing relevant information to stakeholders.

  
  
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  Provide technical writing support for Standard Operating Procedures (SOPs) and related documents.

  
  
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  Collaborate cross-functionally to ensure compliance with quality management systems (QMS) and regulatory requirements.

  
  
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  Utilize Veeva Quality Management System (QMS) to track and manage quality processes.

  
  
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  Apply critical thinking and problem-solving skills to support various quality initiatives.

  
  
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  Use Excel (pivot tables, graph functions, data analysis) to organize and present quality-related data effectively.

  
  
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  Participate in cross-training to gain exposure to different aspects of quality systems.

  
  

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  2+ years of experience with Veeva Quality Management System (QMS)

  
  
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  Hands-on experience with quality systems in a pharmaceutical or biotech setting

  
  
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  Strong critical thinking and problem-solving skills

  
  
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  Excellent project management and organizational abilities

  
  
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  Experience with technical writing, particularly SOPs

  
  
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  Proficiency in Microsoft Excel, including pivot tables and graph functions

  
  

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  Experience working outside of quality systems in pharma/biotech, such as manufacturing

  
  
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  Ability to learn quickly, adapt to new challenges, and work independently

  
  

If you have the necessary skills and are looking for an exciting opportunity in quality systems, apply today!

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.