Quality Assurance Specialist-Documentation

Advantage Technical; Cambridge (MA); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen im Bereich Pharmazeutik sucht einen detailorientierten Quality Assurance Specialist, der Dokumentationen verwaltet und erstellt. Diese Rolle bietet die Möglichkeit, in einem qualitätsorientierten Team zu wachsen und die Dokumentation zu verbessern, die für die Produktqualität und die Einhaltung von Vorschriften entscheidend ist. Wenn Sie Erfahrung in einem regulierten Umfeld haben und gerne in einem unterstützenden QA-Roll arbeiten, ist dies die perfekte Gelegenheit für Sie, um einen positiven Einfluss auf die Qualitätssicherung zu haben.

Benefits

Flexible Arbeitszeiten

Mitarbeiterrabatte

Gesundheitsvorsorge

Berufliche Weiterbildung

Qualifications

• 1-3 Jahre Erfahrung in Qualitätsmanagement in einem regulierten Umfeld.
• Erfahrung mit Veeva oder ähnlichen EDMS ist erforderlich.

Responsibilities

• Verfassen und Verwalten von Dokumentationen innerhalb des Dokumentenkontrollsystems.
• Zusammenarbeit mit funktionsübergreifenden Partnern zur Gewährleistung der Genauigkeit.

Skills

Qualitätsmanagement

Technisches Schreiben

Detailorientierung

Kommunikationsfähigkeiten

Organisationsfähigkeiten

Education

Bachelor in Life Sciences

Bachelor in Technischem Schreiben

Tools

Veeva

LCMS

Microsoft Office

Job description

Job Title: Quality Assurance Specialist - Documentation

Location: Cambridge

Full-Time :Hybrid

Industry: Pharmaceutical / Life Sciences

Precision in documentation. Purpose in every page.

We're seeking a detail-oriented and collaborative Quality Specialist - Documentation to join our pharmaceutical quality team. This role focuses on authoring and managing documentation critical to product quality, compliance, and regulatory success. Ideal for someone with 1-3 years of experience, this position offers the opportunity to grow within a quality-focused organization that values clear communication and continuous improvement.

What You'll Do:

• 
  

  Own and manage documentation within our Document Control System (Veeva, LCMS, or similar)

  
  


• 
  

  Author, redline, and initiate creation and revisions of Finished Goods Specifications

  
  


• 
  

  Upload and maintain all relevant External Manufacturing documentation in the document control system

  
  


• 
  

  Draft and revise controlled documents including SOPs, work instructions, and quality records

  
  


• 
  

  Collaborate with cross-functional partners in QA, Regulatory, Manufacturing, and R&D to ensure accuracy and compliance

  
  


• 
  

  Assist with change control, audit readiness, and version management of key documentation

  
  


• 
  

  Translate complex processes into clear, compliant technical/procedural writing

  
  


• 
  

  Support document lifecycle tasks including routing, approval, release, and archiving

  
  

What You Bring:

• 
  

  1-3 years of experience in quality in a regulated environment

  
  


• 
  

  Experience working with Veeva, LCMS, or similar electronic document management systems (EDMS)

  
  


• 
  

  Proficient in technical writing, especially procedural content in regulated environments

  
  


• 
  

  Working knowledge of FDA/ICH guidelines and cGMP documentation standards

  
  


• 
  

  Detail-oriented with strong organizational and multitasking abilities

  
  


• 
  

  Clear, confident communicator who thrives in a supportive QA role

  
  


• 
  

  Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint)

  
  

Preferred Qualifications:

• 
  

  Bachelor's degree in Life Sciences, Technical Writing, or a related field

  
  


• 
  

  Familiarity with Finished Goods Specifications and external manufacturing processes

  
  

Why Join Us?

We believe in the power of documentation to ensure product integrity, patient safety, and regulatory success. If you enjoy collaborating with teams, improving processes, and producing clear, compliant documents, you'll feel right at home.

Apply today and help us uphold the highest standards in pharmaceutical quality-one document at a time.

After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

About Advantage Technical

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.