Grifols Shared Services North America, Inc.
Quality Assurance Inspector (1st Shift)
Grifols Shared Services North America, Inc., Clayton, North Carolina, United States, 27520
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.
Hours:
1st shift Monday — Friday 5:00 am – 1:30 pm
Summary Quality Assurance Inspectors work with manufacturing operations during the production process, 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). 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
Approve incoming plasma shipment documentation and raw materials by confirming specifications; reject and return unacceptable materials as directed by QA Supervisor.
Generate and document non‑conformance of plasma units or procedures associated with plasma shipments, PUs or final plasma lots.
Approve PUs by confirming customer and regulatory specifications and communicate required adjustments to the QA Supervisor.
Inspect final outgoing plasma lot shipments to ensure all pallets are properly packaged and loaded for sales and distribution.
Investigate and report in‑process/final product and processes that do not meet quality specifications in a deviation report.
Participate in the writing or revision of policies and standard operating procedures related to Source Plasma and quality systems at GPLC.
Execute repetitive functions with strict adherence to procedures and maintain record accountability.
Document 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 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.
Computer literate with experience using 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.
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!
Equal Employment Opportunity Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location NORTH AMERICA : USA : NC‑Clayton:USNC0002 - Clayton
Learn more about Grifols
here .
Requisition Details
Req ID: 537695
Type: Regular Full‑Time
Job Category: PROCUREMENT
#J-18808-Ljbffr
This position is on‑site only at our Clayton, NC Facility.
Hours:
1st shift Monday — Friday 5:00 am – 1:30 pm
Summary Quality Assurance Inspectors work with manufacturing operations during the production process, 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). 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
Approve incoming plasma shipment documentation and raw materials by confirming specifications; reject and return unacceptable materials as directed by QA Supervisor.
Generate and document non‑conformance of plasma units or procedures associated with plasma shipments, PUs or final plasma lots.
Approve PUs by confirming customer and regulatory specifications and communicate required adjustments to the QA Supervisor.
Inspect final outgoing plasma lot shipments to ensure all pallets are properly packaged and loaded for sales and distribution.
Investigate and report in‑process/final product and processes that do not meet quality specifications in a deviation report.
Participate in the writing or revision of policies and standard operating procedures related to Source Plasma and quality systems at GPLC.
Execute repetitive functions with strict adherence to procedures and maintain record accountability.
Document 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 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.
Computer literate with experience using 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.
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!
Equal Employment Opportunity Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location NORTH AMERICA : USA : NC‑Clayton:USNC0002 - Clayton
Learn more about Grifols
here .
Requisition Details
Req ID: 537695
Type: Regular Full‑Time
Job Category: PROCUREMENT
#J-18808-Ljbffr