- Roswell, GA, USA
- Full Time
Medical , Dental, Vision, FSA, HSA, Short Term Disability, Long Term Disability, Life Insurance, Telehealth, 401k and more.
KEY DUTIES AND RESPONSIBILITIES
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.
Participates in daily operations of the Quality department including but not limited to:
- 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 lists updated for control of records/binders.
- 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.
- Batch Records:
- Files all necessary paperwork in batch records (Deviations, NCRs, CAPAs)
- Donor Charts:
- Files copies of Distribution Logs into Donor Charts.
- Files all additional communications of updated donor eligibility into donor charts.
- Uploads and files donor chart documentation such as serology and culture results where applicable.
- 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.).
High school diploma with industry experience or appropriate combination of education and experience. Experience in communication at all levels, meticulous, and self-motivated. Requires basic Microsoft Windows experience (MS Word, Excel, PowerPoint, Outlook etc.).
Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations. Document Control Management (document changes as well as maintenance of Quality records) in a cGMP regulated environment a plus.
Who we are
StimLabs is a regenerative medicine company guided by our desire to innovate and create optimized healing solutions. By bringing together a unique set of skills across tissue engineering, pharmaceuticals, and medical devices, we're reimagining what's possible in regenerative medicine. Our staff, our quality system, and our physical workspace were all meticulously selected with the future in mind.
StimLabs is home to some of the top tissue engineers, inventors, and thought-leaders in the healthcare industry. Combined, these individuals have more than 100 years of experience in healthcare.
We're looking for like-minded individuals who are forward thinking, hard-working, and self-motivated. We pride ourselves in hiring genuine people who are able to work collaboratively towards our vision. We have a united culture where everyone from quality and operations to marketing and product development works together as a team.
StimLabs is an Equal Opportunity Employer