Quality Assurance Coordinator II - Brownsburg, United States - LifeScience Logistics

Description

RESPONSIBILITIES:
Perform all duties from a Quality perspectiveGain a thorough understanding of all LSL Quality documents and proceduresGain a thorough understanding of regulatory requirements related to warehousing and distributing pharmaceuticals, medical devices and healthcare productsProvide Quality training for all facility personnel as assignedReview records and forms for accuracy to ensure compliance with established LSL procedures and regulationsMaintain the Quality files as applicable: Scan, Save to appropriate online storage, filePerform warehouse process walks to ensure SOPs are being followed as written and the facility is maintained in a clean, safe, compliant mannerNotify the Quality Assurance unit of any Quality or inventory concernsRequest Deviations for any Quality related issuesAssist CQCU in developing plans and programs for process improvementCollaborate with all departments to ensure effective Corrective Actions are completed as necessaryAssist CQCU with Internal and External AuditsAssist CQCU with Annual PQ'sAssist CQCU with change requests, reactive maintenance, Deviations/CAPAPerform Hold and ReleasesAssist CQCU with temperature monitoring of controlled environmentsAssist in returns and damages processOther 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 roleExhibits a strong work ethic with leadership abilityDemonstrates sound problem-solving skillsDisplays dedication to a high standard of performanceIntermediate public speaking and presentation skillsExcellent verbal and written communication skillsBecome Familiar with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820Become Familiar with FDA, ISO, DEA and OSHA regulationsWorking knowledge of electronic document and ERP systemsDemonstration of the following:Ability to manage multiple projects and work effectively in cross-functional teams with internal and external customerAttention to detail and organization


TECHNICAL EXPERTISE:
Deftly navigate through Quality and Warehouse Management Systems with training - MQ1, Tecsys EliteBasic to Intermediate Microsoft Office skills: Outlook, Word, Excel, PowerPointConversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820Basic 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 licensePHYSICAL/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 outsideEmployee is subjected to extreme cold while performing duties in the freezerHazardous 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 phoneSystems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (Warehouse Management System), and MQ1 (Quality Management System)NO AGENCIES PLEASEEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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 c)