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About the Role

Works with supervision and senior technical writers to investigate deviations and customer complaints, determine root cause, and initiate corrective/preventative actions. Recommends proactive corrections and preventative actions based on trends to minimize repeat incidents. Manages assigned investigations from initiation to completion with moderate supervision.

Responsibilities

• Ensures compliance with relevant Standard Operating Procedures.
• Gathers, analyzes, and applies information from internal and external sources to perform risk assessments.
• Evaluates the impact of deviations on previously manufactured product and the risk to future operations.
• Prepares and analyzes manufacturing and laboratory analytical historical data.
• Uses methodical root-cause analysis tools to determine root causes and communicates them to senior management.
• Works with Senior Technical Writers/Supervision for root cause analysis development and corrective action proposals.
• Updates and maintains enterprise quality management systems related to investigations.
• Performs trend analysis.
• Complies with procedure-driven guidelines for deviation and complaint investigations.
• Supports management decisions affecting patient health and safety.
• Demonstrates strong technical skills.
• Ensures deadlines are maintained and monitors the need for extensions.
• Accountable for commitments agreed upon with department management.
• Complies with closure targets and provides justification for unmet commitments.
• Ensures compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management System.

Requirements

• Bachelor’s degree with 1-2 years of experience in pharmaceutical manufacturing or cGMP environment.
• Associates 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.
• Good deductive and inductive critical thinking skills.
• 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.
• Ability to effectively speak, read, write, and understand English.
• Ability to independently understand policies, procedures, training materials, and workplace communications written in English.

Skills

• Root cause analysis
• Risk assessment
• Trend analysis
• Technical writing
• Communication
• Critical thinking
• Interpersonal skills
• MS Office (Word, Excel)

Location

• Remote

Work Type

• Full-time

Experience Level

• 1-2 years
• 5+ years

Education Level

• Bachelor's degree
• Associate's degree

Salary/Compensations

• $60,966-$85,694 annually

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability insurance
• 401K with company contribution
• Wellness program

About the Company

• Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.

Equal Opportunity

• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.