Quality Assurance Coordinator II Job at Life Science Logistics LLC, Brownsburg, IN

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  • Life Science Logistics LLC
  • Brownsburg, IN

Job Description

Job Description

Job Description

RESPONSIBILITIES :

  • Perform all duties from a Quality perspective
  • Gain a thorough understanding of all LSL Quality documents and procedures
  • Gain a thorough understanding of regulatory requirements related to warehousing and distributing pharmaceuticals, medical devices and healthcare products
  • Provide Quality training for all facility personnel as assigned
  • Review records and forms for accuracy to ensure compliance with established LSL procedures and regulations
  • Maintain the Quality files as applicable: Scan, Save to appropriate online storage, file
  • Perform warehouse process walks to ensure SOPs are being followed as written and the facility is maintained in a clean, safe, compliant manner
  • Notify the Quality Assurance unit of any Quality or inventory concerns
  • Request Deviations for any Quality related issues
  • Assist CQCU in developing plans and programs for process improvement
  • Collaborate with all departments to ensure effective Corrective Actions are completed as necessary
  • Assist CQCU with Internal and External Audits
  • Assist CQCU with Annual PQ’s
  • Assist CQCU with change requests, reactive maintenance, Deviations/CAPA
  • Perform Hold and Releases
  • Assist CQCU with temperature monitoring of controlled environments
  • Assist in returns and damages process
  • Other duties as assigned

QUALIFICATIONS AND JOB SPECIFICATIONS :

  • High School diploma, GED, or equivalency required. Working on a college degree preferred.
  • Minimum of 1 year experience in Quality logistics role
  • Exhibits a strong work ethic with leadership ability
  • Demonstrates sound problem-solving skills
  • Displays dedication to a high standard of performance
  • Intermediate public speaking and presentation skills
  • Excellent verbal and written communication skills
  • Become Familiar with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
  • Become Familiar with FDA, ISO, DEA and OSHA regulations
  • Working knowledge of electronic document and ERP systems
  • Demonstration of the following:
    • Ability to manage multiple projects and work effectively in cross-functional teams with internal and external customer
    • Attention to detail and organization

TECHNICAL EXPERTISE :

  • Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite
  • Basic to Intermediate Microsoft Office skills: Outlook, Word, Excel, PowerPoint
  • Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
  • Basic comprehension of FDA and DEA regulations

ADDITIONAL EMPLOYMENT REQUIREMENTS:

  • Must be able to successfully pass all preliminary employment requirements (ie, background check and drug screen)
  • Must have a valid driver’s license

PHYSICAL/MENTAL/VISUAL DEMANDS:

  • Work is light to medium in nature with frequent walking to perform assigned tasks.
  • Occasional lifting of up to 50 lbs. may occur.

WORKING CONDITIONS:

  • Activities occur both inside (protected from weather conditions but not temperature changes) and outside
  • Employee is subjected to extreme cold while performing duties in the freezer
  • Hazardous conditions may exist, such as proximity to moving mechanical parts, electrical current, and working in high places

EQUIPMENT OPERATED:

  • Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
  • Systems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (Warehouse Management System), and MQ1 (Quality Management System)

NO AGENCIES PLEASE!

Job Tags

Second job,

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