Quality Control Specialist

QC Specialist

Key Accountabilities:
- Execute lab operations to ensure compliance with GMP principles, data integrity, and good lab practices; QC testing on radioactive material.
- Timely escalate to management for all quality events and investigations.
- Perform QC techniques such as HPLC, GC, TLC, ELISA, and CE-SDS.
- Identify areas of improvement for lab and testing processes.
- Complete routine documentation in compliance with GDP.
- Execute method validation activities, including method development and qualification.
- Review QC testing data for accuracy to support batch release (mAb and small molecule).
- Participate in/perform laboratory investigations (OOS), deviations, and change control; implement CAPAs.
- Manage QC materials (consumables and chemicals).
- Manage laboratory equipment (maintenance, calibration, qualification, requalification, installation).
- Write and update Quality Control procedures.
- Ensure aseptic techniques and GMP principles are followed; adhere to GMP policies and procedures.
- Support FDA/regulatory interactions for Angleton site activities and products.
- Assist QA and other departments with investigations and timely closure.
- Other related duties as assigned.

Education and Experience:
- Bachelor’s degree in chemistry, biochemistry, biology, or related field.
- 3+ years of laboratory experience in a GMP environment.
- GxP manufacturing operations experience (preferred).
- Aseptic technique in controlled areas (preferred).
- Cross-functional collaboration required.
- Ability to work in a team and communicate effectively.
- Willingness to work with radioactive materials and follow strict safety protocols.