Technical Writer

Job responsibilities:

Under minimal supervision, the Quality Specialist, Stability supports the stability program under regulatory requirements and ISO 13485 and runs stability studies from initial batch/lot selection to final report generation and study destruction; works closely with Quality, R&D, and Operations to assure appropriate batch/lot selection, initiation, and execution of Stability studies in a compliant and timely manner.

Job responsibilities:

• Support activities to ensure proper maintenance of the Rocklin stability program
• Analyze and interpret laboratory/stability data
• Draft, review, and update stability protocols upon revisions to specifications, or regulatory requirements
• Generate/review stability study summary reports and verify associated source data
• Own investigations pertaining to OOS and OOT stability results and/or deviations
• Perform impact assessment of temperature/humidity excursions
• Escalate to Quality management any out-of-trend or out-of-specification data immediately upon discovery
• Accurately document all activities with adherence to cGMP and company standards
• Maintain work area and documentation in a neat and organized manner
• Work with computers as well as laboratory software, or proprietary software as needed
• Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to management
• Write, revise, and/or review Standard Operating Procedures (SOPs)
• Adhere to SOPs and GMP regulations and policies
• Support internal and external audits as required
• Maintain current training requirements
• Meet productivity standards without sacrificing quality and safety
• Adhere to established safety procedures; use equipment and materials properly
• Understand, support, and communicate Company mission, vision, and values
• Work on weekends or extended hours as needed
• Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
• Other duties as assigned or required to support the business

Education & experience:

• BS or MS in Chemistry/Biochemistry, Biology or related field
• Minimum 3 years of experience working in a regulated environment which includes stability knowledge/experience
• Experience working in ISO 13485 and/or FDA regulated environment
• Experience in IHC preferred
• Experience with SAP and/or SAP NEXT strongly preferred

Knowledge, skills & abilities:

• Good computer skills, including Microsoft 365
• Good organizational and time management skills
• Ability to work independently and manage multiple priorities with attention to detail Strong technical writing skills
• Strong technical, analytical, and problem-solving skills
• Experience working in ISO 13485 and/or FDA regulated environments
• Knowledge of SAP and/or SAP NEXT strongly preferred