JOB SUMMARY:
The Quality Assurance Coordinator I position assists Corporate Quality Assurance and/or Commercial Quality Assurance Units with implementing and maintaining the Quality System within each applicable local facility.

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)

LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation or gender identity.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Type: Full-time