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
