Quality Specialist Validation
Quality Specialist Validation
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1 Vacancy
Job Description
Job Title: Quality Specialist - Validation
Location: 3902 Madison Ave GBSI Saturn Indianapolis IN - 46227
Start Date: 10/06/2025 to 10/09/2026
Work Schedule: 8 Mon-Fri from 8 AM to 4:30 PM (30-minute lunch break)
Job Description:
- Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation review and approval of validation and quality assurance/control documentation
- Primary Responsibilities of role:
- Assists in the development of cGMP operating procedures that relate to process computer systems and equipment validation
- Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required.
- Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
- Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
- Write test cases to validate critical control points user requirements and functional designs.
- Execute test cases as needed.
- Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
- Assists in analyzing validation data to ensure acceptance criteria are met.
- Assists in writing validation summaries.
- Ensure milestones and timelines are met on assigned projects.
- Prepares validation reports for distribution.
- Evaluates adequacy of corrective actions.
- Participates in the evaluation of processes systems and individual center equipment needs and final approval process:
- Prepares validation equipment for use at the Donor Center and for evaluation upon return.
- Assists in identifying and determining actions to add remove and/or revalidate processes systems and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance transfer or service.
- Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements results from data collected and validation processes.
- Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates requirements results from data collected and validation processes.
- Monitors and trends customer complaints and nonconformance related to equipment failures.
Knowledge skills and abilities:
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
- Excellent quantitative and analytical skills.
- Excellent oral and written communication skills. Strong critical thinking and problem-solving skills.
- Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
Education Requirements:
- Bachelors degree
Occupational Demands:
- Work is performed in an office and in a laboratory/manufacturing environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposed to occasional extreme cold below 32* and high levels of noise in production areas.
- Exposure to electrical office and laboratory equipment.
- Personal protective equipment required such as protective eyewear garments and gloves.
- Frequently sits for 4-6 hours per day.
- May stand; bends and twists neck and waist for 2-4 hours per day.
- Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
- Ability to make precise coordinated movements of the fingers to grasp and manipulate objects.
- Occasionally walks. Repetitive foot movements.
- Light to moderate lifting and carrying objects with a maximum lift of 50lbs.
- Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.
- Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.
- Performs tasks by following a set of written or oral instructions/procedures.
Employment Type
Full-time
