Qa Supervisor Ii/Iii

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Responsible for job assignments and supervising employees engaged in performing various Quality tasks (i.e. documentation review and processing, internal and external audit support, quality agreements, data analysis and reporting, 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.

Primary Responsibilities include, but are not limited to the following:

• Provides effective leadership to employees in Quality.
• Follows cGMP and department safety practices.
• May consult with manufacturing and internal regulatory departments on GXP matters.
• Demonstrated ability to make sound quality decisions with minimal guidance.
• May consult with Quality Management regarding key decisions which need to be made within his/her defined area of responsibility.
• Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
• Provides technical / non-technical expertise on quality related matters.
• Demonstrates high levels of value and integrity.
• Additional responsibilities will include preparation of release protocols and necessary certification for new market registration and license renewal. Support changing market requirements. Maintenance of release certificates of analysis, preparation of periodic RA reports, tracking batch release status including accepted, rejected, reprocessed, and reworked batches. Managing document revisions in support of change controls, projects, continuous improvement initiatives, etc. Support IT projects related to batch release. Assist with tracking media fills and personnel training within the department.
• Directly supervise employees engaged in various Quality 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.
• 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/or supervisors may assign other duties as needed.

Additional Responsibilities

• Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.
• Responsible for representing Quality at business unit meetings, and project meetings.

Knowledge, Skills and Abilities

• Has demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
• Excellent communication skills (written and verbal).
• Prior knowledge and experience with different products, product specifications, different market requirements and regulations is preferred. In addition, knowledge and experience of SAP QM is highly preferred.

Supervisor II

• 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.

Supervisor III

• BS/BA preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience

Experience:

• Please see "Education" section above for minimum requirements.

• 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.

Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex 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. Performs tasks by following a set of written or oral instructions/procedures.