Talent Groups
Our client is looking for a Senior Quality, Document Control specialist to join their team!
On-site in Boston Seaport M-F
6 month contract with high chance of extension!
Pay range: $45-55/hr W2
Skills: document management and GMP
Duration:
6 months to start
Job Description The Senior Document Control Specialist is responsible for overseeing the management, organization, and maintenance of all controlled documents within the company’s 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.
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
Bachelor’s degree in a related field (e.g., Life Sciences, Quality Assurance, or Regulatory Affairs).
Minimum of 5-7 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.
Seniority level
Associate
Employment type
Contract
Job function
Administrative
Pharmaceutical Manufacturing
#J-18808-Ljbffr
On-site in Boston Seaport M-F
6 month contract with high chance of extension!
Pay range: $45-55/hr W2
Skills: document management and GMP
Duration:
6 months to start
Job Description The Senior Document Control Specialist is responsible for overseeing the management, organization, and maintenance of all controlled documents within the company’s 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.
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
Bachelor’s degree in a related field (e.g., Life Sciences, Quality Assurance, or Regulatory Affairs).
Minimum of 5-7 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.
Seniority level
Associate
Employment type
Contract
Job function
Administrative
Pharmaceutical Manufacturing
#J-18808-Ljbffr