Internal/Quality Assurance Auditor

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)