Technical Writer

Fresenius; Melrose Park (IL); Hybrid; USD 70,000 - 85,000; Full time

Benefits offered by this job

401(k) with company contributions

Health, dental and vision coverage

Paid vacation and holidays

Employee assistance program

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL, is seeking a quality investigations professional to independently conduct root-cause analyses of deviations and complaints, initiate CAPAs, and ensure compliance with GMP. You will assess risk to product, process, and patient health, and communicate findings to senior management.

The role requires a BA/BS in science and 3+ years in pharma, plus strong writing and interpersonal communication.

Qualifications

• BA/BS in science field (biology, microbiology, chemistry, pharmacy, etc.).
• Minimum 3 years of pharmaceutical or related work experience with GMP emphasis.
• Advanced writing skills and strong interpersonal, written, and verbal communication.

Responsibilities

• Ensure compliance with SOPs while performing risk assessments on deviations and complaints.
• Gather information from internal/external sources to evaluate impact on product and patient safety.
• Analyze historical data and use root-cause analysis tools to identify and communicate root causes to senior management.
• Advise senior management on corrective/preventive actions to mitigate quality deficiencies.
• Provide technical support to ensure investigations and actions are complete, accurate, and timely.
• Maintain documentation and perform trend analysis in compliance with procedures.

Skills

Critical thinking

Writing skills

Communication skills

Education

BA/BS in science

Tools

MS Office

Job description

Job Summary

Salary Range: $70,000 to $85,000.

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

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Supports either a key site department (i.e., Production, Packaging, QA, Tech Transfer and/or Engineering) to independently conduct a thorough and efficient investigation of process deviations and customer complaints as well as determine 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.

Job 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 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 or managers 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
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Job Requirements

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience
• Minimum of 3 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
• Good deductive and inductive critical thinking skills required.
• Advanced 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.

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.