Job Overview:
* We are seeking a highly skilled and detail-oriented QC Analyst to join our team. In this role, you will be responsible for performing bioanalytical processes to support bulk drug substance manufacture in a cGMP regulatory environment.
* Key responsibilities include reviewing data from other analysts for accuracy and completeness, conducting gels/separations assays (CE-SDS/SDS-PAGE, iCIEF, PICO MCE, Western Blot) in compliance with cGMP practices, and maintaining laboratory reagents and supplies.
* Additional duties may include preparing reagent aliquots and buffers for use in assays, maintaining equipment in the laboratory, and conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT.
* Initiation and completion of CAPAs in accordance with site procedures are also essential.
* Presentation of bioanalytical data reports clearly and concisely to management is required.
* Identify and implement lab process improvements, lean initiatives as needed.
Requirements:
* A minimum of 2+ years' experience working in a regulated testing environment is required.
* Strong trouble-shooting and problem solving skills, along with strong attention to detail & excellent written and oral skills are necessary.
* Current or prior experience working with Gel based Assays is preferred.
Qualifications:
* A Bachelor's degree in Life Sciences or related field or an equivalent combination of education and experience is required.
Benefits:
* Opportunity to work in a dynamic and fast-paced environment.
* Collaborative team atmosphere.
* Ongoing training and development opportunities.
What We Offer:
* Competitive salary and benefits package.
* Flexible work arrangements.
* Professional growth and development opportunities.