QA Specialist, Materials Management

Organization
Spark Therapeutics
Job Location
Philadelphia, PA
Job Description

The QA specialist, materials management is responsible for leading all aspects of materials management functions of the GMP warehouse. This person will manage and execute daily warehousing operations including staging, cycle count, receiving, storage, quarantine and release of materials per SOP, shipping of finished goods and in-direct material. 

RESPONSIBILITIES: 

Receive GMP and non-GMP materials, adjust inventory and perform shipping adjustments and transfer to inter-company locations 
Interface with other departments to ensure that GMP warehouse functions are being performed in a timely and accurate manner 
Ensure and perform material receipt, quarantine, testing and release in accordance with QA procedures 
Perform rejection and disposal/destruction as appropriate 
Initiate and update materials management documentation, such as SOPs, WIs and other GMP documentation 
Document/record and review GMP data and information 
Review GMP documentation for accuracy, quality and compliance 
Provide training in GMP warehouse functions and manage core competence for materials management team 
Support QA management in overseeing day-to-day activities, as needed 
Perform cycle counts, investigate discrepancies and implement corrective measures 
Coordinate and perform validation projects, as needed 
Prepare and track meaningful metrics and procedures to drive process improvement 
Remain knowledgeable and comply with all HAZMAT regulations

Requirements: 

QUALIFICATIONS: 

In depth understanding of materials management, inventory control and cGMPs 
Good understanding of GMP warehouse operations 
Excellent communication and collaborations skills 
Good understanding of inventory control and associated applications (i.e. Oracle and/or SAP, MRP/ASCP, etc.) 
General knowledge of other operational areas such as manufacturing, QC, QA, materials planning, etc. 
Ability to develop solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors and exercise of judgment within defined procedures and practices to determine appropriate action 
Ability to build productive working relationships internally and externally 
Ability to work under only very general supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy 
REQUIREMENTS: 

Bachelor’s degree 
Minimum of 3 years related industry experience 
This position requires physical demands of lifting up to 55 pounds and may involve work with hazardous materials 
This position may require occasional shift work, including weekends, off hours and holidays as needed 
May require up to 10% domestic and international travel

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