Associate Technical Writer (Manufacturing Deviation Investigations)

100% On-Site work, Mon-Fri, 9am to 5pm

Job Summary

Independently responsible for the efficient and thorough investigation of process deviations, determination of root cause, and initiation of corrective/preventative actions (CAPA) designed to adequately address and correct the deficiencies identified during the investigation process. Responsible for providing proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, impact to product or patient/operator safety. Responsible for assisting with process change controls. The position requires working with minimal supervision to manage assigned tasks from initiation to completion.

Job Description

• As part of each investigation, gathers information from all necessary internal and external sources evaluate the root cause of the deviation and impact on all manufactured product, as well as risk to future operations.
• Prepares and analyzes manufacturing and laboratory historical data and uses root-cause analysis tools to determine root cause(s) and apply effective CAPA to mitigate future occurrences.
• Ensures compliance with relevant Standard Operating Procedures (SOPs), while gathering, analyzing, and applying information from internal and external sources to perform a risk assessment of the impact each process deviation has on the product, process, and patient health and safety.
• Works independently to comply with procedure driven guidelines relating to Deviation and Change Control management.
• Ensures that deadlines are met and closely monitors the need for extensions to maintain compliance to site and industry standards.
• Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems and properly assess risk/impact.
• Updates SOPs and/or Manufacturing Batch Records (MBRs), as required, based on CAPA and continuous improvement needs.
• Assists with initiation and completion of change controls, including development of change plan, completion of impact assessment, and management of change.
• Perform any other tasks/duties as assigned by Manufacturing Management.

Requirements

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
• At least three years’ experience in a GMP manufacturing environment. Must be familiar with regulatory (FDA) requirements. Experience in aseptic processing strongly preferred.
• Advanced writing skills.
• Experience with performing and documenting investigations and authoring SOPs and/or MBRs.
• Good deductive and inductive critical thinking skills with attention to detail and ability to manage multiple projects with shifting priorities.
• Must possess strong interpersonal, written, and verbal communication skills. Candidate must be able to interface positively with various department leads, regulatory agencies, and vendors.
• Proficient in MS Office programs, including Word and Excel.
• Prefer candidates proficient with MasterControl QMS.