Technical Writer Job at Kanak Elite Services Inc, California

K01uLzhJYmRobHBDV2RxSVh1ZWxSaU1QSnc9PQ==
  • Kanak Elite Services Inc
  • California

Job Description

need 2 references

po client

rate- $60-$70/hour

no opt,cpt and h1b

A full-service Contract Manufacturing Organization (CMO) client in Carlsbad, CA is in need of a Technical Writer Consultant starting on-site on October 20th, until approximately November 21st. It is projected to be 40 hours/week, fully on-site.

This consultant will be critical in supporting the development and qualification of a new cGMP aseptic fill-finish facility. The CMO specializes in Aseptic Fill & Finish, IVD and Life Science kits, Drug-device combo products, and Lyophilization.

Scope of Work:

  • Review and assemble vendor (OEM) supplied technical documentation and executed validation documents. Author supplemental validation protocols (wrap-around) to support vendor provided validation documents.
  • Author final validation reports from vendor provided executed protocols.
  • Draft and revise SOPs, work instructions, validation plans
  • Have experience with aseptic processing equipment including autoclaves, parts washers, depyrogenation ovens, WFI, clean steam, CCA and other process equipment.
  • Ensure clarity, consistency, and compliance with documentation standards
  • Collaborate with vendors, SMEs, QA, and regulatory teams to gather and verify content.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • Minimum 5 years of technical writing experience in a GMP pharmaceutical or biotech environment.
  • Direct experience with aseptic processing equipment and utility systems (autoclaves, depyrogenation ovens, parts washers, clean steam, WFI, etc.)
  • Strong knowledge of regulatory guidelines: 21 CFR 210/211, 820 , ISO 13485 , and current GMP standards.
  • Proven experience with protocol writing (IQ/OQ), execution oversight, and deviation resolution.
  • Excellent technical writing and documentation skills.
  • Ability to work independently and collaboratively onsite in a regulated environment.

when you feel free please contact me [email protected]

Job Tags

Contract work, H1b,

Similar Jobs

AO Globe Life

Remote Customer Service Representative | No Experience Needed | Work From Home - Start ASAP Job at AO Globe Life

 ...potential . Start this week! Why Youll Love This Job ~100% Work From Home ~$60,000$150,000+ Annually (Commission + Bonuses)~ No...  ...What Youll Do Making outgoing calls, emails, texts and chats from clients Explain and update benefit options Keep accurate... 

iSoftTek Solutions Inc

Technical Manager (R&D) Job at iSoftTek Solutions Inc

 ...The Technical Manager is a pivotal role responsible for leading the transition of formulations from R&D to full-scale production while ensuring the highest quality standards. This role requires deep technical expertise in cosmetic and personal care product formulation,... 

Eureka Labs

Remote Graphic Designer (25GD05D) Job at Eureka Labs

 ...Overview Location: Full remote. Schedule: Full time Job Purpose We are looking for a talented and strategic Graphic Designer to join the team of one of our growth partners, as part of our fast-growing, creative marketing ecosystem. This role is perfect for someone... 

GEOR Global Recruitment (Shenzhen) Ltd.

Office Clerk/Operations Assistant Job at GEOR Global Recruitment (Shenzhen) Ltd.

:1Responsible for the organization, filing and management of daily documents to ensure the accuracy and timeliness of documents.2Assist in dealing with all kinds of daily affairs, and go out to docking related affairs of the U.S. factories according to the requirements...

Wenger Construction, Inc.

Commercial Siding Installer Job at Wenger Construction, Inc.

 ...Summary We are seeking a Siding Installer to join our dynamic team at Wenger Construction. This role is crucial for ensuring high-quality installations across various projects. As an Installer, you will contribute directly to our mission of solving the labor crisis...