Validation Specialist at Austin, TX
Powered by technology and compassionate design, Parachute has reimagined the plasma donation experience into one that is easier and friendlier. Using a simple app, our members can book donations and track earnings from the palm of their hand. In using a tech-forward approach, we’re able to offer each member a highly personable and best-in-class experience that’s consistent at each and every visit.
Our vision is to introduce an elevated plasma donation experience grounded in convenience to markets with smaller populations. This model allows us to positively impact the industry supply chain and help patients gain access to the medication they need.
Come join us as we help the world gain access to more plasma - one donation at a time.
The Validation Specialist is responsible for ensuring current Good Manufacturing Practices (cGMP), and FDA Quality Systems are adhered to throughout the evaluation, review, and approval of validation and quality assurance/control documentation.
Principal Duties & Responsibilities:
- Assists in developing cGMP operating procedures related 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 before 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 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 non-conformance related to equipment failures.
- Lead/Support all information technology validations.
- Ensure information technology validation conforms to all regulations.
- Lead/Support all equipment validations.
- Lead/Support all freezer validations.
- Develop validation plans
- Develop project plans.
- Develop risk management plans.
- Work with project Standard Operating Procedures.
- Draft Installation Qualification, Operational Qualification, and Performance Qualification documentation.
- Work with Corporate Quality department to ensure Qualification documentation is approved.
- Execute Installation Qualification, Operational Qualification, and Performance Qualification documentation.
- Work with Corporate Training, Operations, and Quality to release qualified systems into production.
Knowledge, Skills, & Abilities:
- Ability to write validation plans and related documentation.
- Ability to execute test scripts.
- Extensive knowledge of the principles, procedures, and best practices in the Source Plasma industry.
- Knowledge of the software development life cycle and all associated validation principles.
- Knowledge of software systems.
- 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 and Experience
- Bachelor's degree in Life Sciences or related field or industry experience
- Two (2) years of quality and validation experience in a cGMP environment preferred.
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.