QC Senior Associate (QC Sample Management)

Job Summary:

Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.

Primary Responsibilities:

• Execute sample management activities across the site – sample distribution, LIMS logging, shipment receipt
• Perform Stability Program related activities such as pulling stability samples, study initiations.
• Create/own and approve protocols, sample plans., SOPs, training manuals.
• Perform SAP, LIMS and CIMS functions/ transactions within the sample management remit
• Out of hours responder for sample management equipment (fridges /freezers / incubators)
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities
• LIMS data coordination of commercial and import batches.
• Management and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples.
• QC Representative for NPI activities and routine Product meetings as required.
  
  

Primary knowledge, skills, competencies and relevant experience knowledge:

• Bachelor’s degree in a Science related field is required.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills:
• Take initiative to identify and drive continuous improvements
• Communication skills (verbal and written) at all levels
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
• Ensures compliance within regulatory environment
• Develops solutions to technical problems of moderate complexity
• Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
• Interprets generally defined practices and methods