Manufacturing Technical Writer

Our client, a CMO organization that specializes in formulation development and commercial services for oral solid dosage products is looking for a Manufacturing Technical Writer.

Duties: 

• Author, review and maintain documents (e.g. Standard Operating Procedures, Protocols and Work Instructions) covering Quality Event Records (including deviation, incident reports, planned deviation, Risk Assessments, CAPAs, Change Control documents, and product complaint investigations).
• Participate in the performance and documentation of investigations.
• Prepare and review Out of Specification (OOS) investigations for internal and external analyses.

• Prepare and review Master production and packaging batch records, qualification protocols and validation reports.
• Collaborate with internal stakeholders and subject matter experts to define technical content.

Qualifications: 

• B.S. or higher degree from an accredited college/university in a scientific discipline or English, OR at least 1-5 years of job-related experience or equivalent
• Practical working knowledge of Pharmaceutical Manufacturing Operations
• Ability to interpret complex data and draw valid conclusions
• Continuous working knowledge of applicable cGMP guidelines and DEA regulations Education/Certifications/Licenses/Other
• Must understand how CAPAs (corrective actions/preventive actions) and change controls must be incorporated into a document.
• 2-4 years of experience working within a GMP environment