Susan Cockerham Email & Phone Number

Sacramento, CA, US

Hayward, California, US

I work closely with SMEs and contractors to develop documents for their new pilot plant facility. One of my key accomplishments was creating and editing the operational and maintenance SOPs, as well as commissioning documents.

Alameda, California, US

Working under a very tight deadline, our small collaborative group updated and migrated all controlled company documents into the new document management system - Veeva.After the document migration, I worked with other technical writers in the group as a resource for style guides, reviewing documentation, and providing editing suggestions.

Durham, North Carolina, US

When I first joined the Supply Chain Department, struggling under the weight of the pandemic-caused backlog, I managed both the timelines of the departmental deviations and helped with the investigations. This included running weekly meeting to report out and assess project status. As Corrective and Preventative Actions (CAPAs) were generated as a result.

San Rafael, CA, US

Manufacturing Department: Working collaboratively with document users and SMEs, I drafted and edited SOPs and Batch Production Records (BPRs) with appropriate technical information under 21 CFR 820 regulations. This included constructing graphics to support written content. As documents were approved, training requirements were also tracked and updated.

San Rafael, CA, US

Global Engineering and Facility Services Department:Partnering with global interdisciplinary groups, Project Management Best Practices were created for the global engineering and facilities devices departments. This intensive collaboration included daily meetings with the facility located in Cork Ireland and required creating, adapting, and following.

San Rafael, CA, US

Packaging Operations Department: As part of a new Art Management System upgrade; new procedures, work instructions, and training material were created using explanatory and procedural styles for multiple audiences.

During the validation of the first Samsung Biologics CMO facility in Inchon S. Korea, I created and revised Manufacturing documents ensuring compliance with FDA requirements and improving translations from Korean into English.

Thousand Oaks, CA, US

Partnering with the Manufacturing and Facilities departments, I was responsible for supporting Operations with the upkeep of the clean in place (CIP), steam in place (SIP) systems, and all autoclaves for the Mfg. areas.

Thousand Oaks, CA, US

Partnered with SME representatives from all departments to complete commissioning of a new purification wing at the Amgen Fremont facility. This Included designing, installing, and validation of all new equipment. While managing the tasks of this complex, time-sensitive project, I supported the operational purification wing during their routine.

Bachelor Of Science - B.S., Biology

Master Of Science - M.S., Biological Sciences, Evolution And Ecology