Quality Control Supervisor I/II/III
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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Quality Control Supervisor I/II/III
This position will be responsible for supervising all testing performed on the weekend within the QC Chemistry laboratory. QC Chemistry is a 24-hour, seven days a week operation. Most chemists work 12-hour shifts on the weekend. This position will be a 2nd shift position, working 12 hours on Friday, Saturday and Sunday. The hours will be 2nd shift (approximately 1200 to 2400) which will enable overlap with both the day shift and evening shift. In order to obtain a total of 80 hours per pay period, one additional 8-hour shift per two-week period will be required. The identity of the additional 8-hour shift will be determined between the hiring manager and the selected candidate.
The position will provide both direct (approximately six direct reports) and indirect supervision (approximately six chemists) to multiple 12-hour in-process chemists. Duties will include overseeing the hiring and training of new chemists, coordinating testing needs with manufacturing as well as the rest of the chemistry team and ensuring that all testing is completed in a compliant and accurate manner. Duties will also include performing final data review for data generated by your team and potentially other teams as well. All work is performed within a regulated GMP environment. These in-process testing groups are fast-paced groups that must be able to quickly react when samples arrive. The in-process groups also perform routine testing in between or along with in-process tests. The selected candidate must be able to multi-task and be able to respond quickly to situations that arise. The selected candidate should have some experience with the relevant assays and instrumentation (Atomic Absorption Spectroscopy, Gas Chromatography, UV-VIS-based assays, titrations, and use of various meters).
Quality, Supervisor I, QC
Summary:
Entry level supervisory position in Quality Control (QC) - Responsible for job assignments and supervising employees engaged in performing various QC tasks (i.e. laboratory testing, documentation review, investigations, test release, etc.). Executes assignments of medium complexity, developing solutions for defined problems. Trains others at the entry level. Participates in employee relations matters, performance management and other duties as assigned.
Primary responsibilities for role:
● Directly supervise employees engaged in various QC related tasks as well as assign job duties.
● Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
● Provides technical / non-technical support on quality related matters.
● May consult with manufacturing on GXP matters.
● Follows cGMP and department safety practices.
● Demonstrates high levels of value and integrity.
● Consults QC Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Additional Responsibilities
In addition to the duties described above the Quality Supervisor I - QC may also perform the following duties:
Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations
and write reports. Author SOPs and other laboratory documents. Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects. Serve as system administrator and SME for various laboratory information systems and applications as required.
Knowledge, Skills, and Abilities:
Excellent communication skills (written and verbal) with basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Education & Experience:
BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience. Experience managing, leading, and coaching employees, projects, teams, etc. is recommended.
Quality Supervisor II, QC
Summary:
Responsible for job assignments and supervising employees engaged in performing various Quality Control (QC) tasks (i.e. laboratory testing, documentation review, investigations, test release, etc.). Participates in employee relations matters and is responsible for performance management in area of responsibility. May participates in technical and non-technical training, and other duties as assigned.
Primary responsibilities for role:
● Directly supervise employees engaged in various QC related tasks as well as assign job duties.
● Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
● Provides technical / non-technical support on quality related matters.
● May consult with manufacturing and internal regulatory departments on GXP matters.
● Follows cGMP and department safety practices.
● Provides effective leadership to employees in Quality Control.
● Demonstrates high levels of value and integrity.
● Consults with QC Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Additional Responsibilities:
In addition to the duties described above the Sr. Quality Supervisor II - QC may also perform the following duties based upon the business unit to which he/she is assigned:
Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations and write reports. Author SOPs and other laboratory documents. Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects. Serve as system administrator and SME for various laboratory information systems and applications as required.
Knowledge, Skills, and Abilities:
Excellent communication skills (written and verbal) with basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Education & Experience:
BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 5 yrs of relevant experience or an equivalent combination of education and experience. Experience managing, leading, and coaching employees, projects, teams, etc. is recommended.
Quality Supervisor III, QC
Summary:
Responsible for job assignments and supervising employees engaged in performing various Quality Control (QC) tasks (i.e. laboratory testing, documentation review, investigations, test release, etc.). Participates in employee relations matters and is responsible for performance management in area of responsibility. May participate in technical and non-technical training, and other duties as assigned. May participate on project teams.
Primary responsibilities for role:
● Directly supervise employees engaged in various QC related tasks as well as assign job duties.
● Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
● Provides technical / non-technical support on quality related matters.
● May consult with manufacturing and internal regulatory departments on GXP matters.
● Follows cGMP and department safety practices.
● Provides effective leadership to employees in Quality Control.
● Demonstrates high levels of value and integrity.
● Consults with QC Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Additional Responsibilities:
In addition to the duties described above the Quality Supervisor III - QC may also perform the following duties based upon the business unit to which he/she is assigned:
Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations and write reports. Author SOPs and other laboratory documents. Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects. Serve as system administrator and SME for various laboratory information systems and applications as required.
Knowledge, Skills, and Abilities:
Excellent communication skills (written and verbal) with basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Education & Experience:
BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 6 yrs of relevant experience or an equivalent combination of education and experience. Experience managing, leading, and coaching employees, projects, teams, etc. is recommended
Equivalency:
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 requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
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