Regulatory Compliance Specialist I

RESPONSIBILITIES

:

• Verify Client and Customer licenses to receive and ship product.
• Assist with managing LSL current and new licenses.
• Assist with managing new and existing regulatory registrations.
• Act as subject matter expert for Quality Management Software.
• Author or revise Standard Operating Procedures, Work Instructions, and training modules as assigned.
• Be a part of the internal audit team and lead audits as a certified quality auditor.
• Assist in external audits, as needed.
• Maintain Quality files as applicable, including review of record and forms to ensure compliance with established LSL procedures and regulations.
• Gather and prepare quality metrics, as required monthly and for Management Review.
• Support and assist all departments with research/investigation to maintain compliance with business and regulatory needs.
• Lead change initiatives by identifying best approach for implementing strategic processes.
• Make suggestions on Quality improvements.
• Perform training on Quality related documents when necessary.
• Other duties as assigned.

QUALIFICATIONS AND JOB SPECIFICATIONS

:

• Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred).
• CQIA certification, CQA preferred.
• Minimum of 2-5 years of experience in a Quality role in the medical device or pharmaceutical or other regulated industry.
• Demonstration of the following:
• Effective time management skills
• Impeccable verbal and written communication skills
• Ability to conduct appropriate research as needed
• Strong presentation skills
• Strong analytical skills for safety and compliance
• Attention to detail and organization
• Critical thinking
• Interest to work in a fast-paced environment

TECHNICAL EXPERTISE

:

• Deftly navigate through Quality and Warehouse Management Systems with training.
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
• Knowledge of applicable state and federal laws for warehousing and distribution of pharmaceutical and medical devices as well as the ability to interpret and apply rules and regulations including FDA, DEA, PDMA, DSCSA, ISO 13485, ISO 9001, ISO 14001, FTZ, and CTPAT
• Intermediate public speaking and presentation skills
• Ability to track quality metrics/ trends
• Excellent verbal and written communication skills

ADDITIONAL EMPLOYMENT REQUIREMENTS

• Must be able to successfully pass all preliminary employment requirements (i.e., 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.
• Must be able to safely conduct occasional lifting of 20 to 50 lbs.

WORKING CONDITIONS

• Activities occur within a typical office environment.
• 25% of time is spent in a warehouse setting.

EQUIPMENT OPERATED

• Equipment:  Laptop computer, cell phone, fax machine, copier, and desk phone

• Systems: Outlook, Excel, Word, PowerPoint, and Quality Management Software