Quality Assurance experience in pharmaceutical, plasma/blood banking, or medical device manufacturing.
Working knowledge of cGMP regulations and quality systems.
Experience identifying, documenting, and investigating deviations and non-conformances.
Strong attention to detail with excellent documentation and record-keeping skills.
Effective verbal and written communication skills.
Strong interpersonal skills and ability to work collaboratively with manufacturing personnel and management.
Computer proficiency, including Microsoft Office applications and electronic documentation systems.
Ability to perform basic arithmetic calculations.
High School diploma or GED required.
Minimum of 1 year of Quality Assurance experience and 2 years of pharmaceutical industry experience preferred.
Shifts available:
1st – M-F ; 5 am to 1:30 pm
2nd – M-F ; 1:30 pm to 12 am
Approve incoming plasma shipment documentation and raw materials by verifying specifications and rejecting or returning unacceptable materials as directed by the QA Supervisor.
Inspect and approve in-process Production Units (PUs) to ensure compliance with customer requirements and regulatory standards, communicating any required adjustments.
Inspect final outgoing plasma lot shipments to verify proper packaging, labeling, palletization, and loading for distribution.
Identify, investigate, document, and report non-conformances, deviations, and quality issues involving plasma shipments, production units, and final plasma lots.
Participate in writing, revising, and maintaining quality policies, procedures, and Standard Operating Procedures (SOPs).
Perform repetitive inspection and documentation tasks while maintaining strict adherence to cGMPs, quality procedures, and record accountability.
Accurately document inspection, approval, and quality activities within the organization's computer systems.
Collaborate with manufacturing, quality, and cross-functional teams to resolve quality issues and improve production processes.
Ensure compliance with company quality standards, regulatory requirements, and safety guidelines throughout manufacturing operations.
Quality Assurance Inspectors work with manufacturing operations during the production process, by approving the raw materials and associated documentation for incoming plasma shipments from donor collection centers and the in-process production batches (Production Units - PUs) at the Plasma Logistics Center (PLC). Quality Assurance Inspectors identify and document deviations of both materials and the manufacturing process and ensure these deviations are corrected to ensure a better finished product for prospective customers.