Sr Technical Writer

Fresenius Group; Grand Island, Northern (NE, KY); Hybrid; USD 74,000 - 103,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision

Life insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi in Grand Island, NE, seeks an experienced investigator to lead quality investigations from initiation to completion. You will determine root causes of deviations and customer complaints, initiate corrective actions, and monitor trends to prevent recurrences in a heavily regulated environment.

The role requires 3–5 years in pharmaceutical quality, strong technical writing, and the ability to work with minimal supervision. English proficiency and MS Office skills are essential.

Qualifications

• BA/BS Degree in science field (e.g., Biology, Microbiology, Chemistry, Pharmacy) or equivalent
• 3–5 years pharmaceutical or related work experience with emphasis on cGMP
• Strong deductive/inductive reasoning and advanced technical writing skills

Responsibilities

• Investigate process deviations and customer complaints, determine root cause and initiate corrective/preventive actions
• Gather information from internal/external sources to assess impact on product, process and patient health and safety
• Prepare and analyze historical data; communicate root cause to senior management
• Advise senior management on appropriate corrective/preventive actions
• Ensure investigations comply with procedures and maintain timely closure with justification when deadlines are missed
• Support site quality management systems and perform trend analysis

Skills

Critical thinking

Technical writing

Interpersonal communication

English proficiency

MS Office

Education

BA/BS in science field

Job description

Job Summary

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.

Salary Range: $73,614-$103,000 annually + 6% annual bonus

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Responsible for 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.
• As part of each investigation, gathers 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.
• Prepares and analyzes 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.
• The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
• The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
• Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
• Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
• Demonstrates strong technical skills; provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.
• Ensures 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. Required to comply with closure targets and provide adequate justification if commitments are not met.
• All employees are responsible for 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.
• Any other task as directed or requested by management or site leadership.

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.
• Candidate must possess strong interpersonal, written, and verbal communication skills.
• Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments. Good knowledge of MS Office programs, including Word and Excel.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand Fresenius Kabi have the right to end the employment relationship at any time,in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.