Quality Assurance Specialist I

RESPONSIBILITIES:

• Reviews and approves Change Requests, Reactive Maintenance, Deviations/CAPA as assigned.
• Assist with validations as assigned.
• Review records and forms to ensure compliance with established LSL procedures and regulations.
• Maintain Quality files as applicable: Scan, Save to appropriate online storage, file.
• Perform warehouse walkthroughs to ensure the facility is maintained in a clean, safe, compliant manner.
• Be a part of the internal audit team and assist in external audits.
• Assist with the DEA program.
• Assist QA Supervisor and CQCU in developing plans and programs for process improvement.
• Interact with state and federal agencies, clients, and corporate quality group.
• Plan and present Quality System information to internal and external groups.
• Work with Quality Systems and all levels of facility personnel to achieve company quality standards.
• Perform Holds and Releases as directed by clients which can include template downloads as needed.
• Assist in the Returns, Damage and Recall processes.
• Review and approve inventory adjustments.
• Notify QA Supervisor and CQCU of any unusual trends.
• Perform training on Quality related documents when necessary.
• Other duties as assigned.

QUALIFICATIONS AND JOB SPECIFICATIONS:

• Bachelor of Science (BS) degree in Engineering, Science, or related field preferred
• Minimum of 1-3 years’ experience in a quality role, preferably in a logistics setting
• Conversant with cGMPs, Quality Systems, and CAPAs
• Strong understanding of a 3PL business, audits and complaints procedures
• Medical Device, Pharma and DEA experienced preferred
• Knowledge of electronic document systems
• 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,
  • Critical thinking, and
  • Interest in working in a fast-paced environment.

TECHNICAL EXPERTISE:

• Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
• Certified auditor training per ASQ or ISO (preferred)
• Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA
• Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
• Verifiable aptitude of FDA, OSHA and DEA regulations
• Intermediate public speaking and presentation skills
• Excellent verbal and written communication skills

ADDITIONAL EMPLOYMENT REQUIREMENTS

• Must be able to successfully pass all preliminary employment requirements (ie. 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 25 - 50 lbs
• Ability to handle multiple priorities and solve inquiries and issues expeditiously and efficiently.
• Must be able to read at a distance, close to the eyes, and at arm’s length with or without correction.

WORKING CONDITIONS

• Activities occur within a typical office environment
• 25% of time will be spent in a warehouse setting
• 15 % of time will be spent on key entry

EQUIPMENT OPERATED

• Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
• Systems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS – Warehouse Management System), and MQ1 (Quality Management Software)