Quality Assurance Specialist

Quality Assurance Specialist


Job ID: 9617311

Groveport, OH, US

Scientific

Associate Degree

Full Time, Direct Hire

$25-28/hr.

Entry Level

On-site

Personal Care and Cosmetics

First Shift (Day)

Groveport, OH, US

$25-28/hr.

Entry Level

Full Time, Direct Hire

Personal Care and Cosmetics

On-site

Scientific

Associate Degree

First Shift (Day)

Job details

Job Title: QA Specialist
Location: Groveport, OH
Rate: $25-28/hr. + Benefits
Shift: Mon-Fri | 7am-3:30pm   

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 REQUIREMENTSListed 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.

9617311

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