QA Specialist (contract)

$56,160 - $56,160/Yr

Kelly Services - South Columbus, OH

Full-time - Entry Level

South Columbus, OH

Administrative and Support Services

About the position

The QA Specialist position is a contract role responsible for supporting the Quality Assurance group by inspecting, sampling, and testing products. This role involves maintaining compliance with FDA regulations, training new employees, and ensuring the quality of products throughout the distribution process. The position requires attention to detail and effective communication skills, as it involves interaction with cross-functional teams and documentation of quality assurance activities.

Responsibilities

• 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
• Creating, writing and/or revising SOPs and Batch Records as needed to maintain compliance with all related FDA regulations
• Interacting daily with cross-functional teams to gather information and understand product timelines
• Maintaining all QA systems related to regulated activities within the facility
• 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
• Conducting investigations as required
• Issuing and tracking Non-conformance reports, including closure and completion of corrective and preventative actions
• Issuing deviations for product release
• Providing 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
• Release of packaged product in the inventory control system
• Creating and revising work instructions for the warehouse operations
• Conducting monthly Facility Audits (exterior and interior)
• Cleaning and maintaining Packaging Room
• Conducting equipment and environmental swabbing and testing
• Attending meetings to communicate with facility management, QA management, Planners, and/or cross-functional teams when a product issue arises.

Requirements

• 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

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Telemedicine
• Term life insurance
• Whole life insurance
• Accident insurance
• Critical illness insurance
• Legal plan
• Short-term disability
• Retirement savings plan
• Service bonus
• Holiday pay plans
• Transit spending account
• Paid sick leave