Quality Control Specialist

Jurata Thin Film is a privately held biotechnology company that is revolutionizing the way vaccines and other biological medicines are stored, transported, and distributed. Our thin film technology, which stabilizes biological therapeutic payloads at ambient temperature, is disrupting the current cold-chain distribution ecosystem on which many life-saving biological drugs are currently dependent. We are seeking a Research Associate to join our team. This is an exciting opportunity to help develop a disruptive technology that will change the way critical therapeutics are distributed to those that need them around the world. As an early addition to the research team, input and direction will be a critical expectation of this hire. Therefore, while this requisition specifically seeks expertise in Biological Formulations, we are also looking for an individual who is capable of wearing multiple hats, has a multidisciplinary background, and comfortable delving into areas outside of their comfort zone (i.e., a life-long learner).

Job Description:

1. Perform bioanalytical assays like C12, Luciferase, Western blot, ELISAs and PCR.

2. Conduct routine physical and chemical tests, such as pH measurement, viscosity determination, Karl Fisher’s titration, enumeration, according to approved procedures and compendial methods (e.g., USP, EP, JP).

3. Record test results accurately and timely in laboratory notebooks, electronic systems, and quality records, ensuring compliance with good documentation practices (GDP) and regulatory requirements.

4. Record test results accurately and timely in laboratory notebooks, electronic systems, and quality records, ensuring compliance with good documentation practices (GDP) and regulatory requirements.

5. Investigate and troubleshoot deviations, out-of-specification (OOS) results, and laboratory incidents by conducting root cause analysis, implementing corrective and preventive actions (CAPAs), and documenting findings in investigation reports.

6. Support method transfer, method validation, and stability testing activities by executing protocols, analyzing samples, and interpreting data in accordance with regulatory guidelines and industry best practices.

7. Maintain and calibrate laboratory equipment, instruments, and analytical systems, ensuring their proper functioning, accuracy, and traceability to established standards.

8. Assist in the qualification and validation of analytical methods, equipment, and facilities by participating in validation protocols, executing validation studies, and generating validation reports as required.

9. Collaborate with cross-functional teams to address quality-related issues, implement quality improvements, and support continuous process improvement initiatives.

10. Review and update standard operating procedures (SOPs), test methods, and Quality Control documentation to ensure alignment with current regulations, industry standards, and best practices.

• Bachelor's degree in , Biochemistry, Molecular biology, Pharmaceutical Sciences, or a related field. Advanced degrees or certifications (e.g., ASQ Certified Quality Auditor, Six Sigma) are a plus.
• 2+ years of experience in a Quality Control laboratory within the pharmaceutical, biotechnology, or related industry.
• Strong understanding of cGMP regulations, pharmacopeial standards (e.g., USP, EP), and industry guidelines for pharmaceutical Quality Control.
• Hands-on experience in handling mammalian cells, doing transfection is a plus with analytical techniques and instrumentation, such as HPLC, GC, FTIR, UV-VIS spectroscopy, microbiological assays, and wet chemistry methods.
• Proficiency in data analysis software (e.g., Empower, ChemStation, SoftMax Pro), Microsoft Office applications, and electronic document management systems.
• Excellent communication, organizational, and problem-solving skills, with a commitment to teamwork, integrity, and continuous improvement.

We offer competitive compensation based on qualifications and experience, as well as opportunities for professional growth and development. If you are passionate about scientific research and eager to contribute to cutting-edge projects in the field of Biotechnology, we encourage you to apply.

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Experience:

• Laboratory: 3 years (Required)

Ability to Relocate:

• Houston, TX 77021: Relocate before starting work (Required)

Work Location: In person