RESPONSIBILITIES:

• Manages Processes: Change Requests, Reactive Maintenance, Deviation/CAPA.
• Direct, mentor, train and coach direct reports to support their career goals and LSL pipeline.
• Support Vendor Qualification program
• Support temperature-controlled warehouse requiring scheduled on call duties (minimal).
• Participate and support Internal audit program.
• Assist with DEA program as applicable.
• Lead interface with state, federal, ISO and LSL clients for all unannounced and/or scheduled audits at the facility.
• Work with Quality systems, policies and procedures and all levels of facility personnel to achieve company standards and to ensure regulatory compliance.
• Assist with Holds and Releases as directed by clients.
• Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed.
• Lead change initiatives by identifying best approach for implementing strategic processes.
• Support Quality Management Review process by collecting required QA metrics and highlighting adverse trends.
• This position does provide quality oversight and review of the sampling & dispensing cleanroom generated paperwork.
• 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).
• Minimum of 3-5 years of experience in Quality in the medical device or pharmaceutical or other regulated industry.
• A minimum of two (2) years supervisory experience.
• 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:

• Navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WebCTRL.
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint.
• Strong knowledge of cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820.
• Verifiable aptitude of FDA regulations.
• ASQ and/or ISO Auditor Certifications preferred.
• Intermediate public speaking and presentation skills.
• Ability to track and present quality metrics/trends.

ADDITIONAL EMPLOYMENT REQUIREMENTS

• Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
• Must be able to travel < 10%.
• 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 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 lengthwith or without correction

WORKING CONDITIONS

• Activities occur within a typical office environment.
• 20% 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 CQ (Quality Management Software)

LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation or gender identity.