Technical Writer

About the role

Works with Supervision and Senior Technical Writers to investigate deviations and customer complaints, determine root cause, and initiate corrective/preventative actions designed to address and correct quality-related deficiencies efficiently and thoroughly during the investigation process. Responsible for recommending proactive corrections, corrective actions, and preventative actions based on noted trends to minimize the potential for repeat incidents that may lead to product discards, field actions, or recalls. The position requires managing assigned investigations from initiation to completion with moderate supervision.

Responsibilities

• Ensure compliance with relevant Standard Operating Procedures while gathering, analyzing, and applying information from internal and external sources to perform risk assessments of the impact each process deviation and complaint has on the product, process, and patient health and safety.
• Gather information from all necessary internal and external sources to evaluate the impact of deviations on previously manufactured product and the risk to future operations.
• Prepare and analyze manufacturing and laboratory analytical historical data; use methodical root-cause analysis tools to determine root causes and effectively communicate findings to senior management.
• Collaborate with Senior Technical Writers/Supervision to further develop root cause analysis and proposals for corrective actions.
• Update and maintain all related enterprise quality management systems in compliance with governing procedures and policies; perform trend analysis.
• Work independently to comply with procedure-driven guidelines relating to deviation and complaint investigations; support management decisions affecting patient health and safety.
• Demonstrate strong technical skills and ensure deadlines are maintained; monitor the need for extensions related to Subsequent Actions and Investigations to maintain compliance.
• Accountable for commitments agreed upon with department management; comply with closure targets and provide justification if commitments are not met.
• Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management System as per roles and responsibilities.

Requirements

• Bachelor’s degree with 1-2 years of experience in pharmaceutical manufacturing or cGMP environment, or Associate’s degree with 5+ years of experience in pharmaceutical manufacturing or cGMP environment.
• Working knowledge of GMP, EU, and GLP, as well as FDA trends and guidelines.
• Excellent verbal and written communication skills; strong interpersonal abilities to interface positively with Regulatory Agencies, vendors, and company departments.
• Good deductive and inductive critical thinking skills.
• Proficiency in MS Office programs, including Word and Excel.
• Fluency in English (speaking, reading, writing, and comprehension) to independently understand policies, procedures, training materials, and workplace communications due to the heavily regulated work environment.

Pay

Salary range: $60,966–$85,694 annually. Final pay determinations depend on factors including experience level, education, knowledge, skills, and abilities.

Benefits

• Medical, dental, and vision coverage
• Life insurance
• Disability coverage
• 401K with company contribution
• Wellness program