Scope of Function: The Quality Control Analyst II works in the QC Lab to provide analytical support in the execution of existing analytical techniques, analyzing data and resolving technical issues. They assist in the transfer of new assays from the Characterization group, qualify and validate new or existing assays and support stability studies.
Reports to: Manager, QC Analytical
- Perform all duties in a manner consistent with safety policies, standard operating procedures and GLP/GMP requirements.
- Perform all activities including solutions preparation, cleaning of glassware, equipment verification, methods transfer, qualification and validation to QC department.
- Assist in executing of already implemented assays such as ELISA, SDS-PAGE, IEF, CE-SDS, cIEF, HPLC, A280, BCA, Cell Based Assay, and other pertinent and biological assays as they pertain to GLP and GMP standards to evaluate the In-process samples and Final product as required.
- Participate in reviewing all qualification, Validation, and stability protocols to ensure all the protocols are in compliance with regulatory requirements.
- Execute the QC tests required as part of the release testing and stability studies of Engineering and GMP campaigns.
- Author SOPs, review QC-A data as peer review.
- Collaborate in writing Deviations and OOS.
- Maintain the Laboratory inventory and equipment.
- Perform any other related duties as required or assigned.
Education and Skills Required:
Education: Bachelor of Science in biological or Biochemical sciences preferred, MSc Preferred
Experience: 3 years of work experience in Quality Control and GLP/GMP FDA regulated environment. 3-5 years relevant laboratory experience in ELISA, SDS-PAGE, IEF, CE-SDS. cIEF, HPLC, A280, BCA Cell Based Assay
- Microsoft Office strong computer skills,
- (OpenLab Chemstation, SoftMax Pro GxP,Compass ).
- Detail oriented with good communication skills both written and verbal and an ability to interact with people in a team environment.
- GMP/GLP Knowledge
- Clean room Environment capabilities
- Aseptic Technique