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Assistant Manufacturing Associate

Company: Emergent BioSolutions
Location: Lansing
Posted on: August 23, 2019

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities.

Responsibilities

Manufacturing Responsibilities

General



  • Complete training and demonstrate competency on Assistant Technician qualification blocks in accordance with the training progression pathway
  • Execute and document procedural steps in compliance with cGMP standards, clean room behavior and aseptic technique Standard Operating Procedures
  • Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and company regulations such as the employee handbook
  • Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures

  • Review all documentation generated for accuracy of calculations, data entry and completeness of process signature steps as each step is completed. Perform "real time" review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift
  • Stock gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials

    Lean Concepts



    • Follow standard work guidelines
    • Collaborate with applicable Integrated Process Teams to participate in continuouos improvement and learn new Lean concepts
    • Actively participate in kan ban and 5S systems

      Inspection and Packaging



      • Acknowledge GMPH alarms and perform appropriate follow up to ensure impact to product is minimized
      • Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)
      • Independently operate labeling equipment with minimal supervision (Qualification)
      • Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)
      • Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)

        Behavior/Cultural Responsibilities



        • Action Oriented - Identify and seize new opportunities
        • Resilient - Displays a positive attitude despite adversity
        • Builds Networks - Build strong networks and maintain relationships across the site
        • Collaborate - Partner with others to get work done
        • Communicates Effectively - Effectively communicate with all levels of manufacturing and encourage the open expression of diverse ideas and opinions
        • Courage - Readily tackle tough assignments and support others who do the same
        • Customer Focus - Establishes and maintains effective customer relationships
        • Decision Quality- Rely on analysis, wisdom, experience and judgement when making decisions
        • Accountability - Follow through on commitments and take responsibility for actions
        • Manage Complexity - Acquire data from multiple and diverse sources when solving problems
        • Manage Conflict - Works out tough agreements and settles disputes equitability
        • Optimize Work Processes - Seek ways to improve processes, from small tweaks to larger improvements
        • Self-Development - Learn from new experiences and show personal commitment to continuously improve

          The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

          Education, Experience & Skills



          • HS Diploma
          • 0-1 years experience working in a cGMP environment

          • Knowledge of cGMP and CFR requirements preferred
          • Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware

            Physical/Mental Requirements

            Type/keyboard, visual acuity, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, lift/carry 50

            Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

            Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

            Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent BioSolutions, East Lansing , Assistant Manufacturing Associate, Other , Lansing, Michigan

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