Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.
Position Summary
The AD/QC Specialist position provides laboratory support for Cryoport laboratories in Houston, Texas. The AD/QC Specialist role focuses on GMP and non-GMP testing, executing analytical method transfer, method qualifications and method validation under supervision and coordination of Method SME.
PRIMARY RESPONSIBILITIES (include but are not limited to):
-
Execute compendial and internal methods. Techniques include, but are not limited to, sterility, microbial limits testing, endotoxin, mycoplasma, cell count/viability, and flow cytometry
-
Execute laboratory work plan as per schedule developed with input from supervisor or senior team member
-
Participate in Environmental Monitoring testing
-
Draft development, qualification and/or validation protocols with guidance from supervisor or senior team member
-
Ensure work performed per protocol is accurate and reportable. Prepare summary reports
-
Maintain high quality documentation in accordance with regulatory guidance and site/global SOPs documenting work as appropriate
-
Execute procedures or methods of moderate complexity with high quality
-
Review own and others work to ensure quality, accuracy, and completeness
-
Trend data and regularly observe method performance
-
Able to identify quality/compliance gaps during lab work (OOS/OOT)
-
Draft technical documents with guidance from a supervisor or senior team member
-
Participate in training. Able to execute methods after training schedule
-
Execute laboratory cleaning schedule
-
Assist in the execution of efficiency / compliance work plan as per schedule developed with input from supervisor or senior team member
COMPETENCIES & PERSONAL ATTRIBUTES
-
Positive, proactive attitude. Brings strong core values, quality, ethics, and integrity
-
A collaborative team player who embraces and champions the culture
-
Strong work ethic and ability to deliver results and meet commitments in a dynamic
-
environment
-
Basic understanding of instrument operations and troubleshooting skills in multiple techniques in Microbiology and Cell Therapy
-
Strong written and verbal communication skills
-
Well organized and works effectively under pressure to meet deadlines
-
A willingness to continually embrace personal and professional development
-
Ability to work in global teams, where direct supervisor may occur remotely
-
Passion for, and alignment with Cryoport’s mission
-
A change agent and strong collaborator who is not afraid of challenging status quo
-
Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture
-
Exceptional organizational and planning skills, strong analytical abilities, and process orientation.
-
Attention to detail, accuracy and the ability to prioritize
-
Demonstrates a business process orientation to developing solutions
QUALIFICATIONS AND EDUCATION REQUIREMENTS
-
Bachelor’s degree or higher; Biotechnology/Biomedical
-
QC experience required.
-
At least 3 years’ experience in cell therapy industries/pharmaceutical industries
-
Ability to lift at least 25 lbs.
-
May be required to sit, stand, walk regularly and occasionally lift 0-40 lbs.
-
Proficient with PC and Microsoft Software
Compensation: up to $75K, commensurate with experience
Cryoport Systems is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity (Nasdaq: CYRX).To learn more about Cryoport Systems, please visit
https://www.cryoport.com/
