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Facilities Specialist

SUMMIT, NJ 07901

Posted: 04/26/2023 Job Number: 23731428

Job Description


100% Onsite Position with some flexibility to work remote.
Required Skills:
  • AA / AS degree or acceptable trade certification from technical.
  • Minimum 3 years document management experience.
  • Minimum 3 years in the pharmaceutical industry preferred.
  • Must have a general knowledge of SOP standards.
  • Must have experience with record retention, archival processes.
  • Proficient in cGMP guidelines for documentation management in accordance with company policy and procedures.
  • Complete and review documentation work orders to ensure cGMP good documentation practices and change control procedures are being followed.
  • Expert written and verbal communication skills.
  • Outstanding customer service skills.
  • High proficiency in Microsoft Word, Excel, and Outlook.
  • Ability to meet schedules and timelines.
  • Strong interpersonal skills.
  • Must have strong organizational skills, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required.
  • Must be able to work with limited day-to-day supervision.

Working Conditions:
  • Physical /mental demands:
    • Ability to work a minimum of a 40 hours work week.
    • Ability to sit, stand and move within workspace for extended periods.
  • Environmental conditions:
    • Environment may include working at heights, in cold temperatures, and/or constricted spaces.
    • Ability to work safely when working alone or working with others.
    • Ability to work within a GMP environment and properly gown according to room classifications and procedures.

Project Description:
  • The Facilities Specialist is responsible to manage the documents created by the GMP Facilities Department to ensure that the documents are tracked and organized through the document lifecycle.
  • Respond to Customer requests in a professional and timely manner.
  • Respond in accordance to cGMP policies and procedures.
  • Train colleagues as necessary.
  • Work with internal and external partners. Provide cGMP oversight of GMP documentation to ensure they are operating within the cGMP policies and procedures.
  • Other duties as assigned.
  • Demonstrates and promotes the Client's Values and behaviors.
  • Preparation and distribution of SOPs/WPs for signatures within electronic document management system; as well as organizing, tracking status and timelines.
  • Assist in creating new procedures and providing input on existing for periodic reviews.
  • Support GMP Facilities SOP/WP Administration operations, including individual projects and assignments, as needed.
  • Format technical document according to standard formatting and update of documents to incorporate Subject Matter Expert review comments.
  • Preparation of SOP/WP and supporting documents for submission to the Compliance Wire (training management system) Manager.
  • Track GMP Facility Department Quality Management System actions and provide status updates.
  • Assist in completing Instrument Data Forms to input new or revise instrumentation.
  • Assist in criticality assessments.
  • Responsible for maintenance of Excel spreadsheets for maintenance and tracking of SOPs/WPs.
  • Other responsibilities will include filing of equipment asset documentation and routine and demand work orders.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Vic: vic@alphaconsulting.Com


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Vic Buch

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