Document Control Specialist - SGA Inc.
Boston, CA 02110
About the Job
Software Guidance & Assistance, Inc., (SGA), is searching for a Document Control Specialist for a Contract assignment with one of our premier Healthcare clients in Boston, MA.
Responsibilities :
Required Skills:
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
Responsibilities :
- Participates in global compliance and continuous improvement projects related to Quality System documentation.
- Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
- Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
- Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
- Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)
- Maintains notifications, relations, and other property information within the Document Management System (DMS).
- Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
- Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.
- Collects and reports documentation-related key performance indicator metrics.
- Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).
Required Skills:
- Bachelor's degree (technical/scientific area preferred) or equivalent experience.
- Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems
- 1-2 years' experience using and administering electronic document management tools.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
Source : SGA Inc.