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 and 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/

Job Type: Full-time

Pay: From $70,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance

Schedule:

8 hour shift
Day shift
Monday to Friday
Night shift
Overtime

Work Location: In person

Cryoport System

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AD/QC Specialist