Sr Technical Writer

Fresenius Kabi•Grand Island, NY

About The Position

Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of Product Discards, Field Actions, or Recalls. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

Requirements

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
Good deductive and inductive critical thinking skills required.
Advanced technical writing skills required.
Strong interpersonal, written, and verbal communication skills.
Ability to interface positively with Regulatory Agencies, vendors, and company departments.
Good knowledge of MS Office programs, including Word and Excel.

Responsibilities

Ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.
Gathering information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
Preparing and analyzing manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.
Assessing the manufacturing or analytical environment, independently conceiving, and advising senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
Providing technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
Updating and maintaining all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
Working independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
Demonstrating strong technical skills; provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.
Ensuring that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
Accountable for commitments agreed upon with department management.
Complying with closure targets and providing adequate justification if commitments are not met.
Ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.
Performing any other task as directed or requested by management or site leadership.