More Than Just A Great Place To Work

Shaklee Groveport , OH 43195

Posted 3 weeks ago

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).

MAJOR RESPONSIBILITIES

  • 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

  • Reconciliation

  • 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.

POSITION REQUIREMENTS

  • 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

Physical requirements:

  • 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.

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More Than Just A Great Place To Work

Shaklee