QMS and Compliance Specialist

RESPONSIBILITIES:

• As part of the Corporate Quality Control Unit (CQCU), assist the Director, Managers, and Specialists in day to day activities with the ability to react quickly in changing priorities, as LSL is Client focused and service oriented.
• Manage the licensed company Quality Management Software.
• Manage and initiate change requests when appropriate and coach others on the change process for facilities, equipment and documents.
• Edit and create documents as needed.
• Gather and prepare quality metrics, as required monthly and for Management Review.
• Update data and run reports as requested.
• Gather records in preparation for audits and later ensure each record is returned to its proper storage location.
• Be a part of the internal audit team and assist in external audits, as needed.
• Ensure documents and records are securely stored and easily retrievable.
• Learn and use various quality tools in order to recognize developing trends.
• Verify client and customer licenses for receiving and shipping product.
• Initiate deviations when appropriate and coach others through the deviation process.
• Make suggestions on Quality improvements.
• Other duties as assigned.

QUALIFICATIONS AND JOB SPECIFICATIONS:

• 4-year degree highly preferred; such as Bachelor of Science (B.S.)
• 2 - 4 years’ experience in pharmaceutical and/or medical device industries preferred
• CQIA certification
• Willingness to learn new ideas and apply them to daily tasks
• Demonstrate flexibility working under tight deadlines.

• Organization and attention to detail are key to this position.

Demonstration of the following:

• Effective time management skills
• Impeccable verbal and written communication skills
• Ability to conduct appropriate research as needed
• Strong presentation skills
• Attention to detail and organization
• 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, Adobe Acrobat

• Conversant with cGMPs, Quality Systems, DEA preferred

• Excellent verbal and written communication skills

• Basic to intermediate Technical Writing skills
• Verifiable aptitude of temperature controlled warehousing

ADDITIONAL EMPLOYMENT REQUIREMENTS

• Must be able to satisfactorily pass all preliminary employment requirements (i.e., background check, credit 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 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.
• Occasional lifting of 25 - 50 lbs. is required.

WORKING CONDITIONS

• Activities occur within a typical office environment.
• 10 % of time will be spent in a warehouse setting.

EQUIPMENT OPERATED

• Equipment: Desktop or laptop, fax machine, copier, desk phone, cell phone
• Systems: Outlook, Excel, Word, PowerPoint, and Quality Management Software