Quality Assurance Specialist I

Job Title

Job Description

Provide support during regulatory FDA, DEA, State inspections and customer audits.

Plan and present Quality System information to internal and external groups

Initiate, review, and approve Change Controls, Recalls, Deviations for nonconformances, & Reactive Maintenance

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, take part in Recall

Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs

Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities

Revise SOPs and WIs for process enhancement

Perform Gemba walk applies six sigma concepts such as 5S's

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

Take part on ISM (Inventory System Management) after hours rotation program

Assist in validation projects

Being able to be on call for WebCTRL temperature monitoring on a rotation program

Assist in generating and reviewing temperature monthly reports in a timely manner

Other duties as assigned

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 is preferred

Validation and DEA experience strongly preferred

Medical Device, Pharma, and Plasma experience preferred

Experience in temperature monitoring of controlled environments

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

Take ownership

High standard

Training – public speaking

Ability to take Constructive Criticism

Interest in working in a fast-paced environment

Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRL

Intermediate Microsoft Office skills:
Outlook, Excel, Power Point

Certified auditor training per ASQ or ISO (preferred)

Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferred

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

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

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.

Activities occur within a typical office environment

25% of time is spent in a warehouse setting

Equipment:
Laptop computer, cell phone,copier, and desk phone

Systems:
Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS – Warehouse Management System), and COMPLIANCE QUEST (Quality Management Software)

Life Science Logistics is an equal opportunity employer. Candidates will not be hired based on their race, sex, color, religion or national origin. Reasonable accommodations are available for individuals with disabilities. We proudly support the employment of veterans and welcome applications from protected veterans and all qualified applicants.

* NO AGENCIES PLEASE*

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.