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!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Life Science Logistics
Job Tags
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