Great contract quality role with potential for overtime (up to 10 hrs. per day and 1 Saturday per month) when business needs require it. 

Job Title: QA Specialist (contract)
Location: Groveport, OH
Duration: 3-6 months 
Rate: $27/hr. + Benefits
Shift: Mon-Fri | 7am-3:30pm + 1 Saturday per month  
 
POSITION SUMMARY
This position is responsible for providing support to the Quality Assurance group, to include the inspection, sampling and testing of products.
 
MAJOR RESPONSIBILITIES
 
Supports the Distribution Center operation:

• Sampling and testing of bulk and packaged products
  

• 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
  

• Creates, writes and/or revises SOPs and Batch Records as needed to maintain compliance with all related FDA, etc. regulations
  

• Interacts daily with cross-functional teams within Shaklee 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:

• 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 Groveport Work Instructions
  

• Routinely reviewing the pest control records
  

• Maintaining facility housekeeping records

Conducts investigations as required:  

• Issuing and tracking Non-conformance reports, including closure and completion of corrective and preventative actions
  

• Issuing deviations for product release

Provides support for the packaging process:

• Performing line clearances
  

• Performing in-process inspections
  

• Reviewing documentation regarding line cleaning and set up
  

• Pulling packaging samples for inspection and reconciliation involving quantities, proper assembly, complete seals and quality defects
  

• Release of packaged product in the inventory control system
  

• Creates and revises work instructions for the warehouse operations

Day-to-day support of the distribution center:

• 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.

 
POSITION REQUIREMENTS – Listed in order of importance

• 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

 
This section includes any physical requirements that may be expected of someone as a result of the position held. This is necessary to be in compliance with the Americans with Disabilities Act.

• 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.

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