At Therion we are driven by our mission to Extend and Improve the Lives of Cancer Patients. If you are interested in a fast-changing, dynamic environment in a biotechnology company that is pioneering novel immune therapies for cancer, then Therion is the right company for you.
We are seeking a strong QA professional to participate in routine Quality Assurance documentation activities which include document change control, document issuance and record retention. Candidate must possess a strong familiarity with GxP regulations. Responsibilities include the maintenance of quality documentation systems, which include records control and records retention procedures. Issue production batch records, standard operating procedures and controlled forms. Perform the controlled changes to written procedures such as: typing and formatting of new and revised SOP�s and BPRs; issuing approved documents to all SOP book holders; and implementing revision control procedures, numbering, and storage systems for documentation. Monitor, improve and report on the document control processes. Ensure that operating and change control procedures are brought into compliance with GxPs, flagging issues as needed.
Interact with personnel to ensure GxP documentation compliance and assist in the development of Standard Operating Procedures (SOPs).
We are looking for candidates that embrace our core values of Integrity, Innovation, Collaboration, Compassion, Commitment and Excellence we also ask that you have a B.S. degree or equivalent, preferably in a scientific field with 2+ years of experience in QA functions in a GMP environment. Must understand underlying fundamental principles and concepts as well as GxP that relate to performance of job function. Must possess good communication, interpersonal/team skills and project management skills. Experience with evaluating, implementing and management of an electronic document management systems is a plus. Good computer skills, including MS Word, Excel, Access and Filemaker Pro; Specific skills as needed.
For full immediate consideration, interested, qualified candidates are encouraged to email their resume and cover letter to:
[email protected]
Therion Biologics Corporation
Human Resources
76 Rogers Street
Cambridge, MA 02142
Fax: (617) 475-7249
For more information on Therion please see our website at www.therionbio.com
Therion is an equal opportunity employer.
