Job Description :
Compliance Specialist
6 Months
Novato,CA
Duties:
This role provides support to Manufacturing for a variety of Compliance functions.
This is primarily a service related function to maintain optimal continuity and quality of Manufacturing operations. A key job function includes ownership of change control records and controlled document revisions. Changes will related to Supplier Changes, Manufacturing procedures and raw material specifications. This role also has an emphasis on harmonization of procedures between Manufacturing facilities. Collaboration with multiple other departments is required, including Facilities, Purchasing, QA Lot Release, QA Technical Services. Training of multiple staff or departments is occasionally required for this role.
Skills:
Experience working with Trackwise is highly preferred and a huge plus.
Technical writing experience is preferred (academic writing is acceptable
Strong communication skills are critical to the role; able to understand and explain complex systems.
Experience working with editing and formatting documents in Microsoft Word
General understanding of cGMP requirements as it pertains to therapeutic manufacturing processes.
Good interpersonal skills which promote cross-functional collaboration.
Experience writing technical reports and working on projects.
Understands quality control and regulatory aspects of cGMP production of therapeutic enzymes.
Self-driven, with a strong work ethic and comfortable working independently and in teams.
Strong organizational skills and attention to detail
Skills:
Bachelor of Science (B.S is preferred. In lieu of a B.S., a combination of 2-4 years of experience and some Health Sciences or Biology education is also acceptable.
CGMP
CHANGE CONTROL
MANUFACTURING PROCESSES
TRACKWISE