HireTalent - Staffing & Recruiting Firm · 13 hours ago
QC Analyst I
HireTalent is a staffing and recruiting firm, and they are seeking a QC Analyst I to perform direct materials testing in accordance with cGMP regulations. The role involves executing laboratory testing, conducting trend analysis, and supporting discrepancies along with other laboratory activities.
DeliveryHuman ResourcesStaffing Agency
Responsibilities
Perform a broad variety of basic and moderately complex tests with documentation according to GMP
Review data and assess against established acceptance criteria
Perform technical review of peer-generated data
Evaluate data to identify trends and/or establish limits
Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
Identify and troubleshoot technical problems
Identify gaps in systems and procedures
Receive and provide training
Participate in assay transfer and assay validation
Perform equipment qualification / maintenance
Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
Support the maintenance and compliance of operational areas
Assure and apply GMP throughout operations
Coordinate with customers to support multi-site operational activities
Support internal and external audits and regulatory inspections
Works to meet schedules, timelines, deadlines
Participate in and/or lead group and project teamwork; project and process improvements
Write protocols and reports under limited supervision
Meets scheduled performance of 95% on time
Perform other duties as requested by managers to support Quality activities
Qualification
Required
B.S./B.A. degree and 1-3 years experience or Master's Degree plus one year experience or an equivalent combination of education and experience
Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry
Strong verbal and written communication skills, ability to organize and present information both formally and informally
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures
Routinely exercises sound judgment, reasoning and problem solving
Capable of working under limited supervision and determining own short term priorities
Company
HireTalent - Staffing & Recruiting Firm
HireTalent is a certified Minority Business Enterprise (MBE) workforce solutions firm, specializing in securing the best talent fits in Executive/Retained Search, Direct Hire Placements, MSP, SOW, and nationwide hiring program management and support.