Job Description

Job Title: Technical Writer

**Location: 5 Research Court, Rockville, MD, USA, 20850

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Duration: 6 Months contract (possible extension)

**Pay-rate range: $27/hr. on w2.

Shift:

Mon - Fri**

**

**

**Key Responsibilities and Duties: **

• Training and Documentation Management.

• Writing deviations experience is must.

• Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements.

• Partner with MS&T and Training to conduct training programs for manufacturing staff to ensure adherence to cGMP, process guidelines, and quality requirements.

• Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.

**Qualifications: **

• Bachelor’s degree in relevant Science or Engineering discipline preferred.
• Minimum 3 years working within industry.
• Strong technical writing capabilities a plus.
• Experience within cell/gene therapies, biologics, and/or cGMP regulated environment preferred
• Knowledge of process improvement and lean methodologies preferred.
• Ability to interpret and present complex scientific data in a clear and concise manner.
• Proficient in Microsoft office suite and document management systems.
• Strong organizational and project management skills.

You should be proficient in:

• Bachelor's Degree
• Standard Operating Procedures (SOPs)
• cGMP
• Microsft suite
• MS&T
• Technical writing
• writing deviation
• Manufacturing compliance