Senior Document Control Specialist
Location
Roswell, GA | United States
Job description
StimLabs is looking to hire a Senior Document Control Specialist to join our Document Control for a 6-month contract with the ability to convert to direct hire. This person would work cross-functionally with all the departments of our organization. The Senior Document Control Specialist reports directly to our Director of Quality Control, and works out of our Roswell, Georgia office.
Provides key Quality support to the StimLabs organization - Acts as a quality representative within the organization, raising awareness for quality.
- Contributes to the organization of quality documents.
- Assists on a variety of projects and participates in daily Quality activities.
- Suggests and assists with continuous improvement projects within the Quality System.
- Serve as Administrator of Master Control software for all Quality System modules.
- Key member of quality system transition project(s) for electronic platform upgrades.
- Publication and administration for all new, obsoleted, revisions of controlled documents.
- Monitors document approval requirements
- Collaborates with Training Associate for new and revised document training needs
- Provides guidance and direction cross-functionally for company document control needs.
- Serve as first level escalation and primary for management escalations and area needs.
- Supports company growth for tissue, medical device and pharmaceutical document control requirements.
- Supports company growth for tissue, medical device and pharmaceutical Master Control software needs.
Participates in daily operations of the Quality department including but not limited to: - Manages the administration of Document Control activities.
- Performs quality verification of document approvals prior to effectiveness.
- Reviews document implementation, change, deletion for proper change control.
- Assists with records management and the Document Control system.
- Maintains and ensures all quality documents are scanned and saved on the server.
- Files all paperwork in the correct locations.
- Keeps official documents lists updated for control of records/binders.
- Supports the employee training program associated with new hire orientation, implementation, or change.
- Assists in organizing, scanning, and saving Supplier files.
- Support inspections and audits from regulatory agencies, as needed.
- General administrative tasks such as scheduling, filing, organizing etc.
- Responsible for archival of records.
- Batch Records: Files all necessary paperwork in batch records (Deviations, NCRs, CAPAs)
- Donor Charts: Files copies of Distribution Logs into Donor Charts as needed; Files all additional communications of updated donor eligibility into donor charts as requested; Uploads and files donor chart documentation such as serology and culture results where applicable.
- Design History Records: Files all necessary paperwork for Design History Files
- Proficient in using Windows and applicable applications.
- Schedules meetings where appropriate.
- Other Quality functions as designated and trained by Management (e.g., Releasing batch records, Tissue Utilization Records, Environmental Monitoring, Supplier File Maintenance, Quality Review of records, etc.)
EDUCATION/CERTIFICATION - Associate degree with 5 years of industry experience or equivalent.
- Experience in communication at all levels, meticulous, and self-motivated.
- Requires basic Microsoft Windows experience (MS Word, Excel, PowerPoint, Outlook, etc.).
REQUIRED KNOWLEDGE - Functional with decision-making ability of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations.
- Master Control Administration and Document Control Management in a cGMP-regulated environment a plus.
StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the untapped synergy at the intersection of these independent domains. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.
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