Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. The role recommends corrective actions for deviations and ensures compliance with SOPs and cGMPs. It also maintains finished product reserve sampling and FDA retention sample storage areas.

Responsibilities

• Drive a culture of continuous quality improvement through shop-floor presence.
• Act with competency, integrity, and appropriately as Quality Assurance personnel, ensuring adherence to required processes.
• Authorized to stop production activities and contain materials/products immediately upon noting Critical Deviations.
• Escalate isolated and systemic issues to site management, including proposed CAPAs.
• Conduct shop-floor MQA activities covering all production and support processes.
• Perform Weighing and Dispensing verification.
• Oversee Bulk Solution Preparation.
• Verify Component Preparation identification.
• Monitor In-Process Controls.
• Oversee Filling/Lyophilization activities, including Aseptic Gowning Qualification.
• Verify Finishing Activities, including Integrity Testing, adherence to general inspection requirements/timelines, and execution of sampling plans.
• Perform Visual Inspection (AQL).
• Oversee Packaging.
• Ensure adherence to Warehousing/Storage requirements.
• Monitor Facilities and Utilities per required parameters.
• Serve as the QA key contact for shop floor employees.
• Act as the on-floor QA contact to escalate issues and provide real-time documentation requirements/troubleshooting analysis.
• Participate in 5S activities.
• Support investigations and root-cause analyses.
• Review MBRs and logbooks for GMP and procedural compliance.
• Support quality, compliance, and continuous improvement projects.
• Perform special oversight activities as needed, including media fills, repackaging, reworking, and validation/investigation study activities.
• Perform other duties as assigned.

Requirements

• Minimum of High School Diploma with one (1) to three (3) years of work experience required.
• Associate degree or High School diploma with previous related field experience or knowledge of a GMP – regulated industry preferred.
• Knowledge of regulatory requirements and industry/company best practices.
• Competency in different computerized systems (including software).
• Knowledge of Word/Access and Excel applications is a plus.
• Aptitude for understanding the technology employed in production activities.
• Organizational abilities, troubleshooting capabilities, stress resilience, and personal integrity.
• Relevant work experience/functions in production activities.

Skills

• Quality oversight
• Production process support
• Deviation correction
• SOP and cGMP compliance
• Sampling and storage
• Continuous quality improvement
• Problem-solving
• Documentation review
• Investigation support
• Root-cause analysis
• GMP
• cGMP
• SOPs
• Word
• Access
• Excel
• Computerized systems

Work Type

• 2nd Shift
• Monday through Friday

Experience Level

• 1-3 years of work experience

Education Level

• High School Diploma
• Associate degree

Salary/Compensations

• $60,966 - $85,000

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits (medical, prescription drug, dental, and vision coverage)
• Life insurance
• Disability
• Wellness program

About the Company

• Fresenius Kabi is committed to providing comprehensive benefits programs designed to ensure colleagues live healthy lives and have support when needed.

Equal Opportunity

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