Daley and Associates
Senior Document Control Specialist Boston, MA
Daley and Associates, Boston, Massachusetts, us, 02298
Senior Document Control Specialist Boston, MA
Contract:
6 Months (Potential for Extension) Pay Rate:
$45$55 per hour Our client, a leading pharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing innovative therapeutic treatments, is seeking a Senior Document Control Specialist to join their team. This role is critical to maintaining the integrity of the companys Quality Management System (QMS) and supporting efficient, compliant pharmaceutical development and manufacturing operations. Key Responsibilities
Document Management Oversee the complete lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival. Ensure all documents are accurate, current, and easily accessible within the Electronic Document Management System (EDMS). Collaborate cross?functionally to ensure timely document reviews and approvals.
Compliance Maintain compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal quality procedures. Ensure documents are audit?ready and readily available for internal and external inspections.
Process Improvement Identify opportunities to enhance document control processes for greater efficiency and accuracy. Develop, update, and maintain SOPs, work instructions, and training materials related to document control.
Training & Support Provide training and guidance to staff on document control procedures and best practices. Serve as a subject?matter expert (SME) during audits and regulatory inspections.
Reporting & Metrics Generate and analyze document control metrics and performance reports. Present findings and recommend corrective and preventive actions (CAPAs) to management as needed.
Qualifications
Education:
Bachelors degree in Life Sciences, Quality Assurance, Regulatory Affairs, or a related field. Experience:
57 years in document control within the pharmaceutical, biotechnology, or medical device industry. Knowledge:
Strong knowledge of cGMP, GDP, and global regulatory requirements (FDA, EMA, etc.). Technical:
Proficiency with electronic document management systems (EDMS) and related software tools. Skills:
Excellent organizational, communication, and interpersonal skills. Other:
Ability to work independently and collaboratively in a fast?paced, dynamic environment; high attention to detail and strong commitment to accuracy and quality.
Preferred Qualifications
Certification in Document Control or Quality Management. Experience with Lean or Continuous Improvement methodologies. Familiarity with international document control standards and global regulatory frameworks.
If you are interested in this opportunity, please email your resume to Alanna at aross@daleyaa.com. #J-18808-Ljbffr
Contract:
6 Months (Potential for Extension) Pay Rate:
$45$55 per hour Our client, a leading pharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing innovative therapeutic treatments, is seeking a Senior Document Control Specialist to join their team. This role is critical to maintaining the integrity of the companys Quality Management System (QMS) and supporting efficient, compliant pharmaceutical development and manufacturing operations. Key Responsibilities
Document Management Oversee the complete lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival. Ensure all documents are accurate, current, and easily accessible within the Electronic Document Management System (EDMS). Collaborate cross?functionally to ensure timely document reviews and approvals.
Compliance Maintain compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and internal quality procedures. Ensure documents are audit?ready and readily available for internal and external inspections.
Process Improvement Identify opportunities to enhance document control processes for greater efficiency and accuracy. Develop, update, and maintain SOPs, work instructions, and training materials related to document control.
Training & Support Provide training and guidance to staff on document control procedures and best practices. Serve as a subject?matter expert (SME) during audits and regulatory inspections.
Reporting & Metrics Generate and analyze document control metrics and performance reports. Present findings and recommend corrective and preventive actions (CAPAs) to management as needed.
Qualifications
Education:
Bachelors degree in Life Sciences, Quality Assurance, Regulatory Affairs, or a related field. Experience:
57 years in document control within the pharmaceutical, biotechnology, or medical device industry. Knowledge:
Strong knowledge of cGMP, GDP, and global regulatory requirements (FDA, EMA, etc.). Technical:
Proficiency with electronic document management systems (EDMS) and related software tools. Skills:
Excellent organizational, communication, and interpersonal skills. Other:
Ability to work independently and collaboratively in a fast?paced, dynamic environment; high attention to detail and strong commitment to accuracy and quality.
Preferred Qualifications
Certification in Document Control or Quality Management. Experience with Lean or Continuous Improvement methodologies. Familiarity with international document control standards and global regulatory frameworks.
If you are interested in this opportunity, please email your resume to Alanna at aross@daleyaa.com. #J-18808-Ljbffr