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. 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.
