Quality Assurance Supervisor

LifeScience Logistics LLC.; Indiana (PA); On-site; USD 70,000 - 110,000; Full time

Job summary

LifeScience Logistics LLC. seeks a Quality Leader to manage change requests, CAPAs, deviations, and the internal audit program in a regulated environment.

This role supervises staff, mentors team members, and ensures compliance with FDA/ISO requirements while supporting a temperature-controlled warehouse. Qualified candidates have a BS in engineering/science, 3–5 years in quality roles within medical devices or pharma, plus 2+ years supervisory experience and strong communication and analytical

Qualifications

• B.S. degree in Engineering, Science or related field preferred.
• 3–5 years of quality experience in medical device/pharma or regulated industry.
• At least 2 years of supervisory experience.
• Demonstrated research ability, strong communication, and analytical skills.
• Detail orientation, organization, and critical thinking.

Responsibilities

• Lead quality processes: changes, CAPAs, deviations.
• Mentor and coach direct reports to support career goals.
• Support audit programs and regulatory compliance.
• Assist with DEA program and client audits.
• Provide QA metrics and identify adverse trends.
• Train on quality documents and procedures.
• Collaborate with cross-functional teams in a warehouse/office setting.

Skills

Verbal communication

Written communication

Analytical skills

Attention to detail

Critical thinking

Ability to work in fast-paced env

Research ability

Education

B.S. in Engineering/Science or related field

Tools

CQ (Quality Management Software)

Tecsys Elite

WebCTRL

Job description

• Manages Processes: Change Requests, Reactive Maintenance, Deviation/CAPA.
• Direct, mentor, train and coach direct reports to support their career goals and LSL pipeline.
• 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:
• Impeccable verbal and written communication skills
• Ability to conduct appropriate research as needed
• 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.
• 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.

Travel Required

Yes . < 10%

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.