Quality Assurance Coordinator II

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)