What are the responsibilities and job description for the Quality Systems Documentation Specialist II position at Organogenesis?
About Us
We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.
Learn more about Careers at Organogenesis
What You Will Achieve:
This position is responsible for the day to day operation of the Document Control function. Incumbent is responsible for change incorporation, master filing activities and change administration requirements for product documentation and labeling. Device Master Record and Device History Record file maintenance. In addition, performs process improvements within the Document Control Area.
How You Will Achieve It:
- Prepares CO packets for review, tracks COs through the review and approval process and coordinates incorporation of approved changes. Incorporates approved changes / “redlines” to documentation. Supports Change Control System metrics to allow for monitoring of trends, etc.
- Administration and Maintenance of the Quality System documents – Ensures authorizations are maintained for Change Control Board (CCB). Maintains change/revision history, Device History and Device Master Records, Area Reference copies, Oversees Periodic Review documentation, filing and archiving activities. Manages Off-Site Storage Program.
- Master Filing – Produces “original” documentation, verifies the correct incorporation of changes, updates Device Master Record as applicable and verifies master filing activities.
- Customer Service Activities – Interdepartmental copy requests, internal customer inquiries, expedition of interdepartmental copy requests, support interdepartmental research / investigation activities.
- Collaborate with different members of the QA department working in special projects and additional assignments as directed by Supervisor.
