Internal/Quality Assurance Auditor

LifeScience LogisticsDallas, Texas, United StatesOnsite

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)

Life at LifeScience Logistics

Life Science Logistics is committed to offering the highest quality, flexibility, and compliance in healthcare supply chain solutions. We offer a wide range of customizable solutions, including warehousing, distribution, order-to-cash management, quality assurance and regulatory support. Our highly secure, cGMP-compliant, facilities allow our clients to distribute frozen, refrigerated and controlled room temperature products, while outsourcing as much of the process as they desire. Life Science Logistics is Board of Pharmacy-licensed, VAWD-accredited, cGMP-compliant and FDA-licensed. Our can-do attitude sets us apart from our competition, and we pride ourselves on bringing the best technology, quality and intellectual capital to our clients.

Thrive Here & What We Value- Adherence to Strict Appearance Guidelines- PPE Provided for Employee Safety- Hazardous Conditions May Exist in the Workplace- Equipment Operated: Forklift, Floor Scrubber, Pallet Jacks, RF Scan Guns/Scanners- Emphasis on Teamwork and Collaboration- Continuous Improvement and Process Optimization- Personal Growth and Development through Training Opportunities- Safety and Security as Top Priority- Positive Work Environment with Open Communication Channels- Flexible Schedule (No Weekends)- Ability to Prioritize Tasks and Act with Urgency- Good Research Skills, Organized, Knowledgeable about Data Privacy Regulations- Equal Opportunity Employer with Affirmative Action Policies- Importance of Employee Safety through PPE Provision- Maintaining a Sanitary Warehouse Environment