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Quality Assurance Inspector

3 months ago

Clayton, North Carolina, United States GRIFOLS, S.A. Full time


Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.



This position is on-site only at our Clayton, NC Facility.

Second Shift M-Th 1:30PM - 12:00AM

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.

#biomatusa

This position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

Learn more about Grifols