Quality Scientist II

Summary The Quality Scientist II (QSII) position supports Quality Control (QC) by executing department-specific tasks in accordance with applicable cGMPs and in compliance with corporate/site procedures, regulations, and policies. This role coordinates and processes daily samples, working with minimal direction from the Team Leader, to ensure testing is completed accurately and on schedule. The QSII also supports investigations and continuous improvement projects to enhance productivity, compliance, and data quality in the QC laboratories.

Responsibilities •    Perform routine QC testing of in-process samples, blended vaccines, and final containers using good aseptic technique with minimal supervision. •    Perform all applicable Bacteriology/Immunology testing, including (training provided): Mycoplasma, BHI, DNA, Inactivation, Viable Counts, ELISA, PCR, and Extraneous assays. •    Maintain testing schedules, sample flow, and timely communication of testing status with minimal direction. •    Prepare media, buffers, and reagents; label, store, and maintain critical reagents and supplies. •    Understand assay performance, control results, and trending for assigned methods; escalate concerns appropriately. •    Complete documentation, batch record entries, logbooks, and electronic records in compliance with cGMP and data integrity expectations. •    Support laboratory investigations and deviations as needed, including documentation using Method 1 and DMAIC tools, with appropriate input and follow-through. •    Write, execute, and report validation studies, verification activities, and investigational/technical protocols as assigned. •    Technical writing responsibilities, including authoring and revising Standard Operating Procedures (SOPs) and Standard Methods; supporting method revisions and document updates. •    Support technical transfers (e.g., method transfer/validation activities), including documentation support, execution support, and data review. •    Participate in media fill inspections and other compliance activities as assigned. •    Clean, maintain, and monitor laboratory equipment, instrumentation, and controlled areas; perform and document equipment monitoring where required. •    Demonstrate working knowledge of QC software systems used during routine testing (e.g., sample management, data entry, and reporting). •    Perform general laboratory activities including pipetting, pH testing, and appearance testing. •    Follow all Zoetis Quality Standards, policies, procedures, and safety expectations. Education and Experience •    BA/BS in a STEM discipline, or AA with 1–3 years of relevant laboratory experience. •    General working knowledge of Microsoft Word, Excel, and PowerPoint. •    Knowledge of basic GLP requirements and good documentation practices. •    Strong attention to detail; ability to work independently and as part of a team; effective communication across all organizational levels. •    Willingness to embrace change and adjust to shifting priorities in a fast-paced environment. •    Basic problem-solving and troubleshooting skills; able to follow detailed instructions with coaching. •    Expected to gain proficiency in 70% of the testing in a specified area within defined training timelines. Physical Position Requirements •    Ability to walk, sit, or stand for extended periods. •    Ability to reach above shoulder level, bend/stoop, kneel, push/pull, and frequently handle/grip. •    Ability to work a scheduled 40-hour week with overtime as needed. •    Frequent lifting/carrying of 5–25 lbs. •    Regular reaching, bending, stooping, twisting, and repetitive hand/wrist/finger motion. •    Flexibility to cover rotating weekend duties. •    Ability to grasp and manipulate laboratory items such as pipettors, flasks, and bottles.