Quality Assurance Inspector (2nd Shift)

Summary

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.

Primary Responsibilities

• Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor.
• Generates and documents non-conformance of plasma units or procedures associated with plasma shipments, PUs or final plasma lots.
• Approves PUs by confirming customer and regulatory specifications and communicating required adjustments to the QA Supervisor.
• Responsible for inspecting final outgoing plasma lot shipments to ensure all pallets are properly packaged and loaded for sales and distribution.
• Investigates and reports in-process/final product and processes that do not meet quality specifications and document in a deviation report.
• Participates in the writing or revision of policies and standard operating procedures related to Source Plasma and quality systems at GPLC.
• Executes repetitive functions with strict adherence to procedures and maintains record accountability.
• Documents approval activities in the organizations computer system.

Knowledge, Skills, and Abilities

• Good communication skills with the ability to express ideas with clarity and thoroughness in both verbal and written communications.
• Proactive, results oriented with a strong attention to detail.
• Strong interpersonal skills to interface with manufacturing operators and various levels of management as well as with support and service departments.
• Ability to work in a team-oriented environment and follow safety guidelines.
• Must be computer literate with experience in the use of Microsoft applications.
• Able to perform basic arithmetic functions including addition, subtraction, multiplication, division and using decimals.

Education and Experience

• High School diploma or GED.
• Typically requires a minimum of 1 year of Quality Assurance related experience and 2 years working in pharmaceuticals. Experience in the pharmaceutical, plasma/blood banking or medical device industry is ideal and working knowledge of cGMP helpful.
• Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.