Overview
Technical Writer Jobs in Rocklin, California, USA at Integrated Resources, Inc ( IRI )
Hiring Clinical/ Regulatory Professionals!!
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 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
Seniority level
Associate
Employment type
Contract
Job function
Other
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr
Title: Technical Writer
Company: Integrated Resources, Inc ( IRI )
Location: Rocklin, California, USA
Category: Quality Assurance – QA/QC (Data Analyst)
