Quality Assurance Technical Writer

Quality Assurance Technical Writer
Noblesville, IN - ONSITE
 
Responsibilities:

• Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
• Author and revise technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
• Author and manage change controls as necessary to implement new procedures as well as revisions to documentation and SOPs to facilitate launch of new products. 
• Participate in process and equipment testing to learn systems being documented. 
• Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Coordinate with operations, R&D, and quality representatives to ensure all project documentation requirements are achieved.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements:

• Bachelor Degree within the Life Sciences
• 3 years of pharmaceutical experience required.
• Must be able to communicate clearly in English and have solid communication skills including grammar and composition. 
• Demonstrated understanding of GMP / cGMP regulations.
• Experience with deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Experience with authoring and revising technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
• Proficient in computer skills and experience with Microsoft Word, PowerPoint, and Excel.
  

Min Pay Rate - $30.00/hr.
Max Pay Rate - $35.00/hr.

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Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.  All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.