Supervisor II/III - Quality Assurance
NC-Clayton, US
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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. |
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Schedule: First Shift
Job Description:
The Quality Assurance Final Container Release group is seeking a results driven Supervisor who demonstrates high energy, strong initiative and a consistent record of high performance. The ideal candidate is a highly organized self‑starter who thrives on responsibility, brings energy to daily operations, and consistently delivers results. They are comfortable working independently while effectively leading and motivating others toward company goals and expectations. They can adapt quickly to the fast-paced, dynamic environment associated with supplying biological products to the market.
The Quality Assurance Supervisor II/III is a fully qualified professional who requires minimal supervision and is responsible for performing tasks and making decisions related to batch release. He/she may also participate in cross-functional teams of varying scope and provide leadership and guidance to others.
Responsibilities include:
- Supervision of a group of employees performing tasks and assignments related to final batch release for market distribution
- Motivate and assist teams in the prioritization or weekly, monthly, quarterly and yearly batch release goals
- Identify opportunities, solve problems and improve processes related to final batch release.
- Proactively identify and address issues before they impact final batch release dates.
- Create and edit templates for batch Certificates of Analysis for released batches.
- Create and maintain lists of reprocessed, reworked, rejected batches for Inspections and audits
- Create lists of batches released for use in APRs and audits/inspections.
- Ensure product batches meet the release requirements prior to final release
- Upload Certificates of Analysis to PediGri
- Maintain and make edits to the Viral Risk Assessment computer program used for batch release
- Maintain various excel spreadsheets for tracking batch releases
- Troubleshoot SAP issues
- Participation in project meetings related to batch release
- Follow cGMP and department safety practices.
- Demonstrate high levels of values and integrity.
- Makes sound quality decisions with minimal guidance
- Represent QA FC Release at meetings and projects
- Perform advanced roles related to SAP Batch Release and SAP Quality Module
- Maintain QA Release SOPs and Checklists
Education and Requirements:
Candidates for the Supervisor II-QA: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.
Candidates for the Supervisor III-QA: BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 6 years relevant experience, or equivalent combination of education and experience.
Occupational Demands:
Work is performed in an office environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups.
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; 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