Digital Prospectors
Senior Quality Document Control Specialist
Digital Prospectors, Boston, Massachusetts, us, 02298
Position
Senior Quality Document Control Specialist Location
Boston, MA (Onsite) Length
6+ months Note
W2 Candidates Only, without Sponsorship, No C2C Job Description
Our client is seeking an experienced Senior Quality Document Control Specialist to oversee and manage the lifecycle of controlled documents within a regulated Quality Management System (QMS). This role is critical in ensuring compliance with cGMP, GDP, and industry standards, while supporting the efficient operation of pharmaceutical development and manufacturing processes. The successful candidate will collaborate with cross-functional teams, maintain audit readiness, and drive continuous improvements in document management practices within a dynamic and fast-paced environment. Essential Duties and Responsibilities
Oversee the creation, review, approval, revision, distribution, and archival of controlled documents. Ensure documents are current, accurate, and easily accessible within the electronic document management system (EDMS). Partner with cross-functional stakeholders to ensure timely document updates and approvals. Ensure document control activities comply with cGMP, GDP, and applicable regulatory requirements. Maintain audit readiness and provide documentation support during internal and external inspections. Identify opportunities to streamline and enhance document control processes. Develop and maintain SOPs, work instructions, and training materials related to document control. Train and support employees on document management processes and tools. Serve as a subject matter expert during audits and regulatory inspections. Generate reports and metrics to track document control performance. Present findings and recommend corrective or preventive actions to management. Qualifications
Bachelor's degree in Life Sciences, Quality Assurance, Regulatory Affairs, or related field. 5-7 years of document control experience in pharmaceutical, biotechnology, or medical device industries. Strong knowledge of cGMP, GDP, and regulatory guidelines (FDA, EMA). Proficiency with electronic document management systems (EDMS). Excellent organizational, communication, and interpersonal skills. Ability to thrive in a fast-paced environment with strong attention to detail. Certification in Document Control or Quality Management is preferred. Experience with lean or continuous improvement methodologies is a plus. Familiarity with international document control standards and global regulatory expectations is a plus. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today! www.LoveYourJob.com
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Senior Quality Document Control Specialist Location
Boston, MA (Onsite) Length
6+ months Note
W2 Candidates Only, without Sponsorship, No C2C Job Description
Our client is seeking an experienced Senior Quality Document Control Specialist to oversee and manage the lifecycle of controlled documents within a regulated Quality Management System (QMS). This role is critical in ensuring compliance with cGMP, GDP, and industry standards, while supporting the efficient operation of pharmaceutical development and manufacturing processes. The successful candidate will collaborate with cross-functional teams, maintain audit readiness, and drive continuous improvements in document management practices within a dynamic and fast-paced environment. Essential Duties and Responsibilities
Oversee the creation, review, approval, revision, distribution, and archival of controlled documents. Ensure documents are current, accurate, and easily accessible within the electronic document management system (EDMS). Partner with cross-functional stakeholders to ensure timely document updates and approvals. Ensure document control activities comply with cGMP, GDP, and applicable regulatory requirements. Maintain audit readiness and provide documentation support during internal and external inspections. Identify opportunities to streamline and enhance document control processes. Develop and maintain SOPs, work instructions, and training materials related to document control. Train and support employees on document management processes and tools. Serve as a subject matter expert during audits and regulatory inspections. Generate reports and metrics to track document control performance. Present findings and recommend corrective or preventive actions to management. Qualifications
Bachelor's degree in Life Sciences, Quality Assurance, Regulatory Affairs, or related field. 5-7 years of document control experience in pharmaceutical, biotechnology, or medical device industries. Strong knowledge of cGMP, GDP, and regulatory guidelines (FDA, EMA). Proficiency with electronic document management systems (EDMS). Excellent organizational, communication, and interpersonal skills. Ability to thrive in a fast-paced environment with strong attention to detail. Certification in Document Control or Quality Management is preferred. Experience with lean or continuous improvement methodologies is a plus. Familiarity with international document control standards and global regulatory expectations is a plus. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today! www.LoveYourJob.com
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