Sr. Specialist, QA OTF

This position may follow a 7AM-7PM 2-2-3 rotating schedule and is 100% on site at the Baltimore, MD facility.Our Client is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and employee.The Role:Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product - 80% of day is spent on the floor.Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing; partners with Manufacturing and other support teamsPerforms Acceptable Quality Limit (AQL) visual inspection of drug product; reviews and approves batch documents for media and buffer prep solutions; generates or revises GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's; compile deviations as required when observed on the floor, and move to completion within the required time framePerform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation PracticesIdentifies and implements continuous improvement initiatives; participate in site and corporate quality and process improvement initiatives; makes solid quality decisions with limited oversightGuides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.Actively participates in training activities, managing their individual training plan.Other duties as assigned.The Candidate:Masters' degree in a Scientific, Engineering or Biotech field with 2+ years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor's degree in a Scientific, Engineering or Biotech field with 4+ years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish; have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, EDMS and Trackwise knowledge preferred.Creative individual with excellent analytical, trouble shooting, and decision-making skills; ability to quickly learn new and novel manufacturing processes supporting new clientsAble to work in a team setting and independently, under supervision Requires the ability to produce results in a fast-paced environment to meet client deadlines