Job Description
Job Description
Job Description
Responsibilities
- 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, Deviation 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
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 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
Technical Expertise
- Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, 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 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
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
- Hybrid (1 Day can be worked from home, this is based off business demands)
- Activities occur within a typical office environment
- 25% of time is spent in a warehouse setting
Equipment Operated
- 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)
* NO AGENCIES PLEASE *
Job Tags
Second job, Work at office,