Technical Writer job in Rocklin, CA
Vacancy has expired
Rocklin, CA CorTech LLC
| Job Ref: | 353547 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 30.00/Per Hour |
| Remote: | No |
Location |
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| City: | Rocklin, CA |
| Post Code: | 95677 |
| Map: |
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Description |
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JobsRUs.com. is seeking to hire a Technical Writer for our client in Rocklin, CA! Benefits Available! Weekly Pay! $30.00/Hour Quality Specialist/ Technical Writer - primary responsibility will be to write, revise, and/or review Standard Operating Procedures (SOPs) PRIMARY OBJECTIVE OF POSITION: 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 | |
ref: (353547)
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