Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.

Our lead therapeutics are in the following indications:

• Spinal Fusion
• Long Bone Repair
• Osteochondral Repair
• Dental and Facial Bone Repair
• Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects. At Theradaptive, you will experience the challenge and satisfaction of the therapeutic product development process firsthand, bridging both Biologics and Device fields. Transform your career and join the Theradaptive team today!

POSITION SUMMARY:

We are seeking a talented QA/QC Specialist to be part of our growing team. The QA/QC Specialist will participate in a wide range of activities that support the implementation of a Quality System that is compliant with FDA regulations and industry standards.  The QA/QC Specialist will play a major role in developing procedures that capture our quality practices, documenting the output of these procedures, and monitoring the compliance and effectiveness of these procedures within our company. The QA/QC Specialist will also serve as a coordinator of Quality department owned procedures, such as document control and equipment management.

RESPONSIBILITIES:

• Serving as a Document Coordinator in our eQMS software, coordinating the review, approval, and distribution of revision-controlled documentation.
• Serving as an Equipment Coordinator in our eQMS software, coordinating the introduction and annual maintenance of R&D laboratory equipment.
• Reviewing, approving, and archiving records generated by R&D for compliance with quality procedures and good documentation practices
• Assisting in organizing clinical trial documents and performing QC of clinical Trial Master Files.
• Creating training materials and documenting operating procedures.
• Working closely with R&D to develop statistical sampling plans and acceptance criteria on incoming materials.
• Performing routine inspections and quality tests.

QUALIFICATIONS:

• BA/BS degree required.
• Two years of relevant industry experience required.
• Understanding of QMS required.
• Previous experience in quality assurance or a similar field desired, specifically in processing controlled documents.
• Familiarity with tools, methods, and concepts of quality assurance and quality control.
• Familiarity with sampling tables and techniques preferred.
• Solid knowledge of relevant regulatory standards preferred.  ISO 13485, CFR 21 Part 820
• Knowledge of Design Control preferred.
• Self-starter with strong attention to detail, organization, and time management skills.
• Excellent communication skills, both verbal and written.
• Strong data collection and analytical skills.

PHYSICAL DEMANDS:

• Light lifting

POSITION LOCATION:

• Theradaptive corporate headquarters and laboratory in Frederick, MD.

https://www.theradaptive.com

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.