For 23 years StemCyte has been a leading global regenerative therapeutic company, offering both public and private umbilical cord blood banking. StemCyte’s history started with a mission to help physicians save more lives by providing high quality, safe and effective stem cell transplantation and therapy to patients in need. As a pioneer in the area of regenerative medicine, StemCyte is actively involved in the development of new stem cell therapies to treat a wide range of different disease states.
Job Description:
- Responsible for the overall coordination of controlled documents within the company.
- Collect and maintain files of the latest revision level documentation necessary to define product configuration and control manufacturing processes.
- Timely distribution of the latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
- Maintain a computer database of all filed documentation that ensures fast retrieval of documents.
- Support user requests for documentation and train users in document control database.
- Maintain quality-controlled documents per applicable SOPs (i.e., forms, job aids).
- Responsible for coordinating document change control, facilitates review, approval and release of documents.
- Coordinate quality training program for new hires and maintains all employee training records.
- Investigate and respond to corrective actions related to Document Control and Training.
- Perform occasional desk audits of documents and training records.
- Maintain and track company’s blood and tissue licenses and operating permits, and assist in preparing responses to the various agencies who issue them.
- Assist in the qualification of new vendors and managing annual vendor surveys.
- Provide backup assistance to NCR coordinator in the tracking and trending of positive sterilities.
- Review critical materials requests and work with the lab to approve materials for use.
- Prepare internal department memoranda and external business correspondence.
- Other duties may be assigned as needed.
Minimum Qualifications/Skills:
- Two years of relevant document control experience.
- BS/BA degree
- Demonstrate strong analytical, problem solving, and organizational skills related to Quality Assurance
- Ability to self-motivate, prioritize, multitask and demonstrate careful attention to detail
- Strong work ethic, team player, adaptation to fast-paced environment and works well under pressure
- Able to work independently with minimal supervision and maximum professionalism
- Must possess excellent oral and written communication skills
- Must be proficient in Microsoft Word and Outlook
- Electronic document control such as; Perfecta
Job Type: Full-time
Pay: $25.00 - $27.32 per hour
Benefits:
- 401(k)
- AD&D insurance
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Education:
Experience:
- document control: 2 years (Preferred)
Work Location: In person