CMA/Facility Environmental Control Specialist

Posting Date 2 weeks ago(9/16/2020 2:32 PM)
Requisition ID
2020-7862
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc.
Category
Facilities/Maintenance

Overview

The Controlled Manufacturing Area (CMA)/Facility Environmental Control Specialist at Cook Incorporated will serve as the contamination control process owner and liaison between operations within the CMA, facility engineering, supplier group and the QAC Laboratory.  They will review quality standards and tolerances to make recommendations for improvement, contamination control strategies and assure quality in accordance with good manufacturing practices (GMP), federal regulations, acceptance sampling and monitoring systems.

Responsibilities

• Regularly applies theories and principles for one's technical discipline
• Works independently to solve problems of moderate scope
• Actively participates, suggest solutions to problems
• Serve as a liaison between operations within the CMA, engineering, supplier group and the QAC Laboratory to ensure items being requested, purchased and used in the CMA have been approved for use
• Ensure all CMA cleaning materials, chemicals, etc. are evaluated / analyzed, documented and approved
• Ensure all CMA Gowning materials, soaps, sanitizers, etc. are evaluated / analyzed documented and approved
• Ensure all CMA equipment and materials (i.e. chairs, floor mats, workstation components, etc.) are evaluated / analyzed documented and approved
• Maintain an accurate controlled list of evaluated / analyzed documented and approved items (i.e. Quality System Approved Products for use in CMA for Environmental Control Purposes)
• Develop and maintain controlled housekeeping procedures for the CMA, as well as other quality system procedures and instruction that apply to contamination control
• Ensure continued improvement on CMA environmental challenges / opportunities and documentation
• Understand and conform to Corporate and Quality standards such as: Quality System Regulation (QSR), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP)
• Work with industry experts/consultants to create specifications, general arrangement drawings, user requirements, functional specifications, and contamination control strategies
• Ensure compliance with all applicable company, federal, and local safety and environmental regulations, guidelines and policies and ensuring effective use of material, equipment and personnel throughout the CMA

• Self-starting, results-oriented individual with demonstrated ability to work in a team while also being productive independently
• Perform additional duties as identified / needed
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

Qualifications

• Bachelors Degree in Chemistry, Biology, Engineering or related field, or experience of such kind and amount as to provide a comparable background
• 2 - 5 yeas of experience in a regulated industry
• Working knowledge of Microsoft Office (i.e. Excel, Word and Outlook)
• Basic knowledge of medical device manufacturing
• Able to follow and understand system procedures, quality document instructions and comply with GMP / QSR / GDP
• Must have excellent written and verbal communication skills

 

Physical Requirements:

• Ability to lift and/or move up to 50 pounds.
• Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, as well as those requiring manual labor, effective listening and communication

• Must be able to perform essential job functions

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