Quality - FACILITIES SPECIALIST FACILITIES SPECIALIST

Company: Eclaro
Location: Summit
Posted on: May 28, 2023

Job Description:

Facilities SpecialistJob Number: 23-01128 Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Facilities Specialist for our client in Summit, NJ. Eclaro's client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity! Position Overview: 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. Required Skills: Be 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. Responsibilities: General Roles Working under minimal direction and guidance and be self-motivated, responsibilities shall include but not be limited to the following; 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 Client Values and behaviors. Document Coordinator Technical Requirements Must have strong organization 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. Must have a general knowledge of SOP standards. Must have experience with record retention, archival processes. Must have experience with electronic document management systems. Strong PC skills to include: Microsoft Excel and Word Excellent written and oral communication skills. Document Coordinator Technical Administrative Requirements 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. Qualifications: AA / AS degree or acceptable trade certification from technical Minimum 3 years document management experience. Minimum 3 years in the Pharmaceutical industry preferred. If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If interested, you may contact:Jay Lucasarjay.lucas@eclaro.com6463571240Jay Lucas - LinkedIn Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.PDN-9909133a-2430-431f-a103-ac9fb9924684

Keywords: Eclaro, New York , Quality - FACILITIES SPECIALIST FACILITIES SPECIALIST, Other , Summit, New York