Senior QC Analyst
A challenging opportunity has arisen for an experienced senior quality control analyst to join a dynamic analytical team in a leading biopharmaceutical company.
Responsibilities:
* Conduct testing of in-process, stability, and finished product samples using advanced analytical techniques such as HPLC, CE, SDS-PAGE, and IEF.
* Review and authorize laboratory data to ensure accuracy and compliance with regulatory standards.
* Support analytical technical transfer activities by testing reports and documentation.
* Maintain equipment calibration, perform routine maintenance, and troubleshoot issues.
* Develop and validate methods for analytical testing.
* Provide training and guidance to QC chemistry laboratory colleagues.
* Investigate laboratory incidents and maintain GMP standards.
* Assist in regulatory audits to ensure compliance with industry regulations.
Requirements:
* Bachelor's degree in biochemistry, chemistry, biology, or biotechnology, or equivalent scientific discipline.
* At least 3-5 years of experience in a pharmaceutical or healthcare environment.
* Proven expertise in analytical techniques such as HPLC, CE, SDS-PAGE, and IEF.
* Proficiency in Microsoft Office software and strong technical writing skills.
* Detail-oriented, self-motivated, and able to work independently.
* Excellent teamwork and communication skills.
* Ability to meet deadlines and prioritize tasks effectively.
Desirable Skills:
* Significant experience in executing HPLC analysis.
* GMP laboratory experience is essential, with biopharmaceutical experience being an advantage.
* Proficiency in LIMS/LMES and Empower software.