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Document Control Specialist

Company: Kedrion Biopharma
Location: Melville
Posted on: November 19, 2021

Job Description:

Job Scope: The Document Control Specialist is responsible for reviewing, providing, categorizing and filing all Engineering documents, commissioning, turn over packages, work orders relating to maintenance and calibration activities at the Melville site. In addition, this role supports the EMU department by maintaining training documentation and using the SAP system for purchasing parts and materials as well reserving materials. Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. Main Responsibilities: Work Orders and Preventive Maintenance paperwork:

  • Manages the filing of documents and completed work orders to ensure control and availability of documentation to site personnel
  • Reviews documentation in support of cGMP requirements
  • Maintains and files records, reports, logs, etc.
  • Help updating work instruction procedures, SOPs, GMP records, Non-GMP records and other controlled documents
  • Submits documents to internal and external customers as requested
  • Coordinates storage of active and expired recordsTraining:
    • Monitor's training status of the whole Engineering and Maintenance Department and provides and reviews training assessments.
    • Maintains department training binders
    • Updates Quality department on individuals training statusSAP Purchase Requisitions and Materials reservations:
      • Supports the Engineering and Maintenance department in issuing Purchase Requisitions
      • Supports the maintenance department in performing materials reservationsEngineering:
        • Manage the storage of Engineering Documentation such as Turn Over Packages, Other Commissioning Documentation, Equipment Manuals, Engineering Drawings, GMP Drawings and other Engineering Documentation.Performs other related duties as assigned by managementSkills & Technical Expertise:
          • Working knowledge of cGMPs and FDA regulations as it pertains to document control
          • Flexibility to changing priorities, work schedule, and the needs of the business
          • Ability to work independently and in a team environment
          • Read, write, and speak English. Strong written / oral communication skills.
          • Ability to perform basic math
          • Ability to follow instructions
          • Good attendance and punctuality
          • Expert proficiency in using Microsoft Word, Excel and Outlook
          • Ability to work well under pressure
          • Track Wise experience preferred.Highly organized / detail oriented with ability to work effectively in a fast-paced work environmentMeasurement of Performance:
            • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
            • Timeliness and accuracy in completion of projects and paperwork (quantity of work)
            • Contributions to projects beyond general responsibilities (quality of work)
            • Identification of problem areas affecting operations (knowledge/problem solving)
            • Offers suggestions for correcting problems and for improving operations
            • Exercises good judgment in dealing with operational problems
            • Understanding of theory, rationale behind tasks performed
            • Demonstrated understanding and adherence to Kedrion policies, safety procedures and the cGMPs
            • Ability to succeed in a team-oriented environment under very dynamic conditionsQualifications:
              • Requires a High School Diploma or higher. AAS preferred.
              • Requires 2 years of quality pharmaceutical experience with relevant document control experience.

Keywords: Kedrion Biopharma, New Haven , Document Control Specialist, Other , Melville, Connecticut

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