What are the responsibilities and job description for the Internal/Quality Assurance Auditor position at Life Science Logistics LLC?

Job Description

Responsibilities

Develop and lead the internal audit plan, which will include on-site and virtual audits of LSL facilities with the support of the audit team
Develop internal reporting plan for audit results and observations including metrics for internal management reviews
Administrator for the internal audit program within LSL’s eQMS
Develop, train and internally certify new employees to participate in the internal audit program
Lead internal meetings regarding audit observations and remediation plans
Other duties as assigned by supervisor

Qualifications and Job Specifications

4-year degree highly preferred, such as Bachelors of Science (B.S.)

3-5 years’ experience in pharmaceutical and / or medical device industries preferred

3-5 years' audit experience in an internal or external audit capacity

ASQ and or ISO Auditor Certifications required

Technical Expertise

Deftly navigate through Quality and Warehouse Management Systems with training (ComplianceQuest and Tecsys Elite WMS)

Intermediate Microsoft Office skills : Outlook, Excel, PowerPoint, Adobe Acrobat

Conversant with cGMPs / cGDPs, Quality Systems, DEA (Preferred)

Intermediate Technical Writing skills

Verifiable aptitude of temperature-controlled warehousing

Additional Employment Requirements

Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)

Must have a valid Drivers License

Travel is required for in-person audits

Physical / Mental / Visual Demands

Work is light to medium in nature

Must be able to read at a distance, close to the eyes, and at arm’s length, with or without correction

Ability to handle multiple priorities expeditiously and efficiently

Working Conditions

Activities occur both inside and outside.

Hazardous conditions may exist, such as proximity to moving mechanical parts.

Equipment Operated

Equipment : Laptop Computer, Cell Phone, Copier

Systems : Outlook, Excel, Word, PowerPoint, and MQ1 and Compliance Quest (Quality Management Software)

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