This position is responsible for providing support to the Quality Assurance group at our Groveport, OH Distribution Center. It is primarily responsible for inspection, sampling, testing of products received, assembled or packaged at this facility. Other responsibilities include: maintenance of the QA databases used to track product status, supporting Groveport Operations with the packaging processes and quality checks, maintaining documentation, internal audit support, training, providing inspection support during a regulatory inspection, writing or revising SOPs, and providing general QA/QC support (sanitation verification, assistance in failure investigations, special projects).
Supports the Distribution Center operation including, but not limited to the following:
Sampling and testing of bulk and packaged product
Occasional testing of labels, components, and packaging materials
Making product status changes (Quarantine, Hold, Release, and Reject) as required.
Witnessing and documenting product destruction as necessary
Reviewing contract manufacturer Certificates of Analysis (CofAs) and Certificates of Manufacture for release of product
Maintaining packaging equipment documentation and log books
Maintaining all related documentation for each product evaluation and ensure that all logs and databases are correct
Creating and maintaining FDA required reserve samples
Training new employees on approved QA SOPs
Other duties, as assigned
Writes and/or revises SOPs as needed to maintain compliance with all related FDA, etc. regulations
Interacts daily with cross-functional teams to gather information and understand product timelines
Maintains all QA systems related to regulated activities within the facility and all associated documentation, with particular attention to those QA/QC activities related to the receipt, inspection, testing, packaging, assembly, storage and distribution of regulated products and their packaging components
This includes the following:
Tracking and updating employee training
Issuing and tracking variances, including closure and completion of corrective and preventative actions
Issuing and tracking equipment logs
Controlling and updating issued SOP and Form binders
Processing and issuing approved Distribution Center Work Instructions
Routinely reviewing the pest control records
Maintaining facility housekeeping records
Conducts investigations as required including completion of employee documentation, including:
Issuing and tracking Non-conformance reports, including closure and completion of corrective and preventative actions
Issuing deviations for product release
Provides support for the kitting process which includes:
Performing line clearances
Performing in-process inspections
Reviewing kitting records
Release of kits/product
Creates and revises work instructions for the warehouse operations
Day to day support of the Distribution Center including the following:
Monthly Facility Audits (exterior and interior)
Cleaning and maintaining Packaging Room
Equipment and environmental swabbing and testing
Line-Clearances for Packaging Room
Attends meetings to communicate with facility management, QA management, Planners, and/or cross-functional teams, when a product issue arises.
Occasionally travels to vendor locations to address vendor-compliance issues as needed and to ensure the Company's quality standards are observed during production.
BS degree from an accredited university
3-5 years related experience in a regulated industry preferred
2-3 years of QA/QC experience
Effective writing and interpersonal communication skills
Ability to effectively use MS Word, Excel and Access (preferred)
Organized with specific attention to detail skills
Ability to travel up to 2% domestically for training
Ability and willingness to work extended hour shifts if needed, work a flexible schedule that may include Sundays and work up to 7:30 p.m. if needed
Must be able to lift 40 pounds with frequency when required. Must be able to stand for extended periods of time when required on the warehouse floor performing QA and QC functions.
Mental Requirements:Requires ability to work independently, gather information quickly to make difficult decisions that will impact the supply-chain, effectively analyze job specific situations and issues, effectively write reports and documentation, and make proper QA/QC related decisions with appropriate judgment and timing.
Tools or Equipment: Effective knowledge and hands-on use of computers, word processing, spreadsheet programs, data base software applications and warehouse/packaging related equipment.
Local candidates preferred as we are not in the position to offer relocation.