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PDS Tech Inc Documentation Administrator in Middletown, Virginia

PDS Tech, Inc. is seeking a Documentation Administrator in Middletown, VA

Position Summary:

  • We welcome your interest in the QC Documentation Associate position within the company in Middletown, VA. The work performed within the QC department is crucial to evaluating the efficacy and performance of each of the Invitro Diagnostics products we manufacture at the site, which are used to diagnose a variety of medical conditions. Members of the QC department represent a team of professionals possessing an extensive technical background who have been trained to evaluate a variety of medical products involving Analytical and Clinical Chemistry, Clinical and Environmental Microbiology, Hematology, and Immunology testing. Lab assignments rely on the application of standalone and automated systems.

Key Responsibilities:

  • Accurate and efficient revision of all production and testing documents.

  • Assist with trial and experimental activities and the control of the documents that include Product Master Records, Batch Records, Forms and SOPs as required by GMP.

  • Assist in production and testing documentation, new and revised, in accordance with GMP/QSR requirements.

  • Initiates and coordinates Change Orders.

  • Controls and maintains Departmental Databases for PMR and specification changes.

  • Assists in the Validation of Departmental Databases.

  • Proofreads corrections made to documents by other Documentation Department Staff.

  • Maintains complete and accurate files of documents under the change control of the Documentation Department as required by GMP.

  • Logs/house Technical Reports, Technical Review Books, Design History Files and Technical Files.

  • Participates in PPI, Kaizen, and JDI events as needed.

  • Represent the team in internal/external projects.

  • Assist/support for transfer projects.

  • Assist Document control team in revising departmental processes to ensure continual improvement.

  • Performs other duties as assigned.

Minimum Requirements/Qualifications :

  • High School Degree required with 2 years relevant experience. Associates degree preferred with knowledge of scientific terminology. Middletown manufacturing processes and GMP desirable. Desk-top publishing skills helpful.

  • Physical Requirements: Normal office environment. Position may require frequent communication and walking to other areas in which designated PPE will be required. Position will require sitting and standing. Additional PPE will be required when working with potentially infectious material or chemical hazards. Employee may occasionally lift and/or move up to 10 pounds.

Non-Negotiable Hiring Criteria:

  • Basic to advanced word-processing skills: familiarity with spreadsheets and database skills (Microsoft Office preferred).

  • Proficiency in typing, proofreading and editing required.

  • Ability to interact with all levels of staff, vendors, and internal and external customers.

  • Strong oral and written communication skills.

  • Excellent organization skills and ability to manage multiple requests/projects, along with rapidly changing priorities.

  • Team player with good interpersonal skills.

  • Ability to exercise good judgment and make decisions within prescribed guidelines.

  • Must demonstrate good safety and quality control.

  • Must be a self-starter with the ability to work independently requiring little or no supervision.

  • Some problem-solving skills.

  • Attention to detail.

  • Professional and courteous attitude.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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