Deviation Specialist/Technical Writer Job

DEVIATION SPECIALIST/TECHNICAL WRITER needed for a CONTRACT opportunity with Yoh's client located in San Carlos, CA.

TOP SKILLS YOU SHOULD POSSESS:

- Experience using Trackwise
- Experience with Quality Assurance
- Bachelors degree
- working in a GMP environment

WHAT YOU'LL BE DOING:

- Performs a wide variety of Technical Documentation and Investigation activities to ensure that the Clinical Manufacturing Unit (CMU) meets its deliverable targets. Ensures that such related activities are compliant with applicable GMP requirements, and Novartis Procedures and Quality Standards. Applies knowledge of Good Manufacturing Practices (GMP) on a daily basis.
- Conducts deviation management related to manufacturing activities
- Initiates deviation in a Trackwise QA database or equivalent
- Conducts investigations to determine root cause using industry tools (eg fishbone analysis)
- Ensures that Corrective and Preventative Actions (CAPAs) are implemented
- Authors and revises Standard Operating Procedures SOPs as needed
- Authors and revises Manufacturing/work instructions (MIs, WIs)
- Collaborates with line units to author/draft batch manufacturing reports (BPRs) and other supporting documentation
- Reviews data audits and report reviews as required
- Supports review of Development (PHAD) protocols
- Participates in the disposition of batches (eg batch record review)
- Provides documentation support to other projects as assigned

WHAT YOU NEED TO BRING TO THE TABLE:

- 3+ years of technical writing experience, preferably in a manufacturing environment
- Experience in pharmaceutical industry working in a GMP environment is required
- Experience with writing and leading product manufacturing investigations
- Experience using Trackwise QA database or database equivalent
- Experience with Quality Assurance (QA) systems
- Strong oral and written communication skills are required
- Must have excellent interpersonal skills
- Computer literacy (MS Word, Excel)

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelors degree in a scientific discipline is recommended or AA with technical background

RECRUITER: Mary Nguyen-Bravo

Yoh, a DayJ2W: SCIENTIFIC ; J2W: PROF

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