Lab Validation Specialist
4 weeks ago
your opportunity to do rewarding work,
your future leadership potential,
and your career growth?
Join an Industry Leader
[Become one, too]
Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:
Laboratory Validation Specialist
This Is What You’ll Do:
- Develop, draft, and perform equipment and system validation documentation including validation plans/strategies, test protocols and scenarios, risk assessments, traceability matrices, and validation summary reports for regulated equipment.
- Review completed validation documentation, as applicable, to ensure actual results match expected results and all deviations that occur during the validation process are resolved appropriately.
- Work with Vendors, Package Inserts, technical documents, etc. to determine requirements for all necessary IQ, OQ, and PQ validations and associated test cases.
- Write necessary validations and test cases for test equipment and support systems as well to evaluate successful use in the laboratory.
- Write validation deviations and perform investigations identified during the validation to ensure all paperwork associated properly defines any nonconformities.
- Provide assistance to designated trainers and lab leadership with writing SOP procedures and training documents related to equipment and systems being validated consistent with FDA and EU regulations and customer requirements.
- Provide technical support for clinical equipment and validated systems throughout the laboratory post go-live, as needed.
- Train individuals on the equipment and validated systems, as required.
- Prepare documentation and maintain records pertaining to all validations performed, meeting all standard cGMP requirements.
- Coordinate the work performed by service contractors and vendors to include maintenance, calibration, and installation and to verify the documentation of the work performed is accurate and complete prior to internal validations.
- Coordinate and/or participate in requests for special projects, such as new equipment acquisition, purchase-planning, development of bid specifications, analysis of vendor proposals, installation planning, acceptance testing, renovations, equipment upgrades and equipment disposal.
- Ensure corrective and preventive actions are developed and implemented in accordance with the Deviation Management System for all validations, as needed.
- Excellent interpersonal skills, strong written and verbal communication skills.
- Highly ambitious and ability to think outside of the box.
- Eager to share new ideas and contribute to a team.
- Self-motivated and willing to assume the initiative.
- Attentive to every detail.
- Capable of thriving while working independently.
- Bachelor’s degree in one of the allied health sciences (chemistry, biology, medical technology), or computer science.
- Must qualify as testing personnel in accordance with CLIA Regulations 493.1423 Standard; Testing Personnel Qualifications and meet California State Department of Health requirements for out of state testing personnel.
- Two (2) years’ experience performing clinical laboratory testing OR experience in performing repair and maintenance of validated medical/clinical equipment.
- Two (2) years' experience in writing and performing validations highly preferred.
- Ability to work diverse shifts and overtime hours, as required.
- Ability to maneuver in tight workspaces, which include those close to the floor, walls, or other pieces of equipment.
- Attention to detail.
- Ability to complete documentation in a clear and accurate manner.
- Ability to apply knowledge of validation principles and compliance standards.
- Understanding of computerized systems and IT change management.
- Ability to work independently assuming leading roles.
- Excellent verbal and written communication skills.
- Ability to multitask between competing projects/deliverables.
- Ability to facilitate meetings and execute training presentations with peers, managers, directors, and senior management.
We’re widely known and respected for our benefits and for leadership that is supportive and hands-on.
- Formal training
- Outstanding plans for medical, dental, and vision insurance
- Health savings account (HSA)
- Employee assistance program (EAP)
- Wellness program
- 401 (k) retirement plan
- Paid time off
- Company-paid holidays
- Personal time
More About Octapharma Plasma, Inc.
With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.
INNER SATISFACTION.
OUTSTANDING IMPACT.
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