Job Details

Job TitleIn this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 6p - 6a, on a 2-2-3 rotation.Key ResponsibilitiesPerform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic techniqueChampions quality culture by aiding personnel in understanding application of policies and controlsParticipates in RAPID event response and provides quality guidance for deviation eventsAdvances deviation events to the appropriate area and quality managementPerforms quality review and approval of procedures, training documents, and forms of moderate to high complexityPerforms quality review and approval of deviation and change control of moderate to high complexityParticipates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexityPerforms quality batch record reviewAids in identification of continuous improvement opportunities; Participates in practical process improvement initiativesQualificationsBachelor's degree, preferably in technology, engineering or microbiology related field required.A minimum of 4 years of experience with previous experience in Quality Assurance or Quality control or Operations/ManufacturingPrevious experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)Ability to capture data, analyze & troubleshooting process issues, equipment problems along with production leadershipAbility to troubleshoot process and equipment issuesHard-working, demonstrated ownership & responsibility.Ability to lead, support & empower a team/peersTechnical Writing experienceProfessional certifications (ex: CQA) and training (Six Sigma) are a plusPrimary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.Physical RequirementsPosition requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.EEO Statement"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."