Job Description

Job Description

Job Description

Description:

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The Operations Event Investigator is responsible for performing Root Cause Analysis (RCA) to determine the most likely cause of Quality Events (i.e., manufacturing deviations, environmental excursions). In this role the Investigator will be responsible for performing impact assessments and risk assessments as well as identifying appropriate and effective Corrective and Preventative Actions. As part of each investigation, the Investigator gathers information from all necessary internal and external sources to determine root cause and evaluate the impact of the Quality Event on manufactured product, as well as to the patient. This will require close collaboration with operations personnel of all levels.

Essential functions:

• Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions.
• Gather data from various sources across the site (ex. video review, trend data, and training records)
• Perform interviews of personnel related to the Quality Events.
• Drive Quality Events to closure within on-time closure commitments.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Implement appropriate Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas.
• Perform assessments for operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements.
• Provide feedback to Operations Management, document observations and track resolutions.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in logbooks.

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline
• 3+ years of operations experience in pharmaceutical, medical device or other related industries
• 2+ years of experience performing investigations and change implementation
• Ability to ensure investigations are founded on LEAN-SIGMA tools
• Must be able to perform and manage DOE (design of experiments)

Desired Knowledge, Skills, and Abilities:

• FDA regulated industry technical writing knowledge and experience
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Excellent organizational, planning, and communication skills
• Ability to problem solve in a cross functional setting.
• Demonstrate strong technical writing skills, decision making abilities, and critical thinking.
• Ability to manage multiple investigations and adhere to on-time closure commitments concurrently.
• Must be able to sit or stand for 5+ hours at a time, as needed.
• Must be able to learn and maintain sterile gowning qualification and wear all required Personal Protective Equipment.

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

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