Quality Control Senior Analyst I

Quality Control Senior Analyst I

Requirements

• Typically requires a bachelor’s degree and 4+ years of related experience. (science related degree would be ideal).
• 5S/OE experience.
• Method transfers.
• Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices.
• MS Office, LIMS, SAP, Trackwise, compliance and strong science understanding.
• Previous experience in a GMP QC role would be ideal.

Responsibilities

• Product testing: Areas of focus on techniques such as Western Blot, SDS-PAGE, ELISA Potency and Bioassays
• Establish and recommend changes to policies which effect subordinate organizations.
• Work is reviewed and measured based on meeting objectives and schedules.
• Provide guidance to subordinates to achieve goals following established policies and receive assignments in the form of objectives and establishes goals to meet objectives.
• Participate in determining objectives of assignments. Plan schedules and arranges own activities in accomplishing objectives. Work may be reviewed upon completion for adequacy in meeting objectives.
• Exert some influence on the objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
• Role is responsible for Cell Biology laboratories performing a broad range of techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing
• Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
• Support Quality projects and implementation of operational excellence initiatives.
• Testing execution, participate in training analysts, trouble shooting of methods
• Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
• QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)

Preferred Qualifications

• Previous experience in a GMP QC role would be ideal.