Technical Writer

About the Company:

Process Alliance is a consulting firm headquartered in Indianapolis, Indiana, specializing in on-site client services across various industries, primarily in pharmaceutical manufacturing. Known for a commitment to being a better model of problem solving, Process Alliance provides tailored solutions that address unique client challenges in areas such as process improvement, technical compliance, and operational efficiency. With a focus on quality and innovation, the company works closely with clients across the U.S. to deliver impactful results that drive sustainable growth and success. Process Alliance is also dedicated to inclusive employment, creating opportunities for individuals facing barriers in the job market.

Key Responsibilities:

• Review, edit, and verify batch records for accuracy, completeness, and compliance with company and regulatory standards.
• Document and correct any errors or inconsistencies in batch records, ensuring all necessary amendments are accurately recorded.
• Ensure batch records are compliant with Good Manufacturing Practices (GMP) and other regulatory requirements.
• Collaborate with production, quality assurance, and other relevant departments to gather required information and resolve discrepancies.
• Maintain thorough documentation of review processes, changes made, and justifications for corrections.
• Develop and maintain standard operating procedures (SOPs) and guidelines for batch record documentation and review.

Qualifications:

• Bachelor’s degree in related field
• Proven experience as a Technical Writer, preferably in a regulated environment (e.g., pharmaceuticals, manufacturing, biotech).
• Exceptional attention to detail and ability to identify discrepancies in documentation.
• Strong knowledge of technical writing standards, regulatory requirements, and GMP (Good Manufacturing Practices).
• Proficient in Microsoft Office Suite (Word, Excel) and familiar with document management systems.
• Excellent communication and organizational skills, with a proactive approach to problem-solving.

Preferred Qualifications:

• Experience in batch record review within a regulated industry.
• Certification in Technical Writing, Quality Assurance, or related field.
• Familiarity with FDA, ISO, or other relevant regulatory standards.