Quality Assurance Inspector (2nd Shift)

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 organization's 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.
• Able 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. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.