QA Specialist

Job Description

JOB SUMMARY:

The Quality Assurance Specialist II position is responsible for maintaining a robust Quality System that assures products and services are reliable, safe, and effective. The QA Specialist II is part of the Quality Control Unit.

RESPONSIBILITIES:

Experience in temperature monitoring of controlled environments

Provide support during regulatory inspections and customer audits.

Plan and present Quality System information to internal and external groups

Demonstrate expert knowledge of Quality Systems

Familiar with Change Controls

Work to maintain Quality Systems policies and procedures to ensure regulatory compliance

Be a part of the internal audit team and assist in external audits

Release “quarantined” product upon receipt of documentation from Client and use Hold and Release process

Review/approve product-specific paperwork particular to Client guidelines

Help guide Operations team in determining root cause of discrepancies and help develop corrective actions and verification activities

Review and approve Deviations and CAPAs

Make suggestions on Quality improvements

Participate in cross-functional initiatives for a 3PL environment

Strong leadership skills and logistics (3PL) knowledge

Able to professionally communicate with customers/clients

Assist in returns and damages process

Perform record reviews to ensure compliance with all applicable procedures and regulations

Other duties as assigned

QUALIFICATIONS and JOB SPECIFICATIONS:

Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferred

Minimum of 1-3 years’ experience in a quality, preferably a logistics role

Strong understanding of a 3PL business, audits and complaints procedures

Validation and DEA experience strongly preferred

Medical Device, Pharma, and Plasma experience preferred

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

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 (i.e., background check and drug screen)

Must be able to travel up to 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 - 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 is spent in a warehouse setting

15 % of time is 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)

Life Science 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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please no agencies!

Company Description

Do you always find a way?

LifeScience Logistics offers a variety of careers in the healthcare supply chain. We are continuously seeking qualified candidates who believe in the power of “yes.” We offer challenging career growth possibilities in an environment that embraces innovation, vision, and unwavering dedication.

To apply, visit