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,