Operational Quality Document and Training Specialist (Contract) 26453
Operational Quality Document and Training Specialist (Contract) 26453
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Job Description
Job Description
The Operational Quality Document and Training Specialist is responsible for overseeing the management organization and maintenance of all controlled documents within the companys quality management system (QMS). This role ensures compliance with regulatory requirements company policies and industry standards supporting the efficient operation of the pharmaceutical development and manufacturing processes.
Key Responsibilities:
Document Management:
- Manage the lifecycle of controlled documents including creation revision review approval distribution and archival
- Ensure documents are accessible accurate and up to date within the electronic document management system (EDMS).
- Coordinate with cross-functional teams to ensure timely review and approval of documents.
Compliance:
- Ensure all document control activities comply with current Good Manufacturing Practices (cGMP) Good Documentation Practices (GDP) and per Vertex Procedures.
- Maintain audit readiness by ensuring documents are in a state of compliance and available for internal and external audits.
Process Improvement:
- Identify and implement process improvements to enhance the efficiency and effectiveness of the document control system.
- Develop and maintain document control procedures work instructions and training materials.
Training & Support:
- Provide training and support to employees on document control processes.
- Act as a subject matter expert for document control during audits and inspections.
- Review documents/training to ensure correct curriculum for the correct role
Reporting & Metrics:
- Generate and analyze document control metrics and reports to monitor performance and identify areas for improvement.
- Present findings to management and recommend corrective actions as needed.
Qualifications:
- Bachelors degree in a related field (e.g. Life Sciences Quality Assurance or Regulatory Affairs).
- Minimum of 2 years of experience in document control within the pharmaceutical biotechnology or medical device industry.
- Strong knowledge of cGMP GDP and regulatory requirements (e.g. FDA EMA).
- Proficiency in using electronic document management systems and other relevant software.
- Excellent organizational communication and interpersonal skills.
- Ability to work independently and as part of a team in a fast-paced dynamic environment.
- Detail-oriented with a commitment to quality and accuracy.
Preferred Qualifications:
- Certification in Document Control or Quality Management
- Experience with lean or continuous improvement methodologies.
- Familiarity with global regulatory requirements and international document control standards.
Pay Range
$45-$50/hr
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employment-related information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Required Experience:
Unclear Seniority
Employment Type
Full-Time
