Job Description

Hiring for -

Job Title : EM/QC Investigations Writer SME

Location : Hickory area, NC

Duration: 3 months to start, likely 6+

Location : On site for the first 5-7 biz days to do reviews of the flooring (ensuring there's nothing porous) and to familiarize themselves on the company's investigation writing process. - Fully remote afterwards

Experience needed:

• Finding and creating investigations for the EM/QC groups
• On site examination of facilities for the first 5-7 days to understand issues
• Aseptic mfg/sterility background
• COMMUNICATION IS KEY - It's important that this person be a fluent and eloquent writer. They had worked with a foreign firm to outsource this writing and there was a steep disconnect between the writings and being able to articulate them to leadership.

Job Description:

We are seeking an experienced EM/QC Investigations Writer Subject Matter Expert (SME) to join our team in North Carolina.

Key Responsibilities:

• Conduct on-site examinations of facilities for the first 5-7 business days to review flooring and ensure there are no porous materials.
• Familiarize with the company's investigation writing process during the initial on-site period.
• Develop and create investigations for the Environmental Monitoring (EM) and Quality Control (QC) groups.
• Ensure thorough documentation and articulation of findings to leadership.
• Maintain a strong aseptic manufacturing and sterility background to support investigation processes.

Experience and Qualifications:

• Proven experience in finding and creating investigations for EM/QC groups.
• Ability to conduct on-site examinations and identify facility issues.
• Strong background in aseptic manufacturing and sterility.
• Exceptional communication skills, with the ability to write fluently and eloquently.
• Experience working with foreign firms and overcoming communication challenges to articulate findings effectively to leadership.

Thanks & Regards

Arun Kumar

Sr. Recruiter

Email: [email protected]

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