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Salary Range

Up to USD36.00/hr

No. of Openings


Branch Information

Irvine, CA - McGaw (USA) 2525 McGaw Avenue CA Irvine , CA 92614

Branch Phone Number


Job Description

Job Summary

Position Summary

Assist multiple departments in the preparation of a variety of technical documents such as procedures, data summaries, protocols, validation and development reports, analytical method and process descriptions and posters and presentations for internal and external dissemination.

What's in it for you?

Full time hours

Competitive wage: $36 per hour

Temp to hire opportunity

What is the job?

Able to benchmark and apply industry best practices.

Review, compare and update current documentation of processes and equipment functionality/design to comply with FDA's Code of Federal Regulations 21 CFR Parts 210 and 211.

Perform and document investigations, CAPAs and effectiveness checks.

Organize, review and interpret statistical data and information from subject SMEs.

Manage multiple projects simultaneously while interacting with various departments, vendors, contractors and clients.

Problem Solving - Ability to solve problems by weighing all the variables to come up with a resolution

Expertise: Knowledge & Skills

Accuracy- Ability to perform work accurately and thoroughly.

Analytical Skills - Ability to use thinking and reasoning to solve a problem.

Communication, Oral & Written- Ability to communicate effectively with others using the spoken word and in composing clear and concise messages

·Conceptual Thinking - Ability to think in terms of abstract ideas.

Customer Oriented- Ability to take care of the customers' needs while following company procedures.

Decision Making -·Ability to make decisions for a course of action to be taken to address a specific issue.

Detail Oriented -Ability to pay attention to the minute details of a project or task.

Organized- Possessing the trait of being organized or following a systematic method of performing a task.


Expertise: Qualifications - Experience/Training/Education/Etc


Bachelor's degree with a minimum of 3 years of writing experience in a device, biopharmaceutical or biotechnology industry.

Familiarity with ICH and FDA guidelines, GMP regulations and quality compliance requirements preferred.

Must have excellent technical writing skills and graphics, editing, formatting and organization skills.

Will need excellent scientific and technical writing abilities and advanced computer skills.

Should be able to present writing samples from publications, preferably as first author.

Proficient in Microsoft Office Suite


Bachelor's degree in Biochemistry, Biology, Chemistry or related scientific field is strongly preferred.

3-5 years pharmaceutical manufacturing or related industry experience preferred.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.