Grifols Shared Services North America, Inc QA Supervisor II / Sr Supervisor Quality in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Responsible for job assignments and supervising employees engaged in performing various Quality Assurance (QA) tasks (i.e. laboratory testing, documentation review, product investigations, product release, internal and external audit support, materials clearance, 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 for role:
● Directly supervise employees engaged in various QA 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 operations.
● Demonstrates high levels of value and integrity.
● Consults with QA Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.
In addition to the duties described above the Sr. Quality Supervisor I/II may also perform the following duties based upon the business unit to which he/she is assigned:
Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control,
Discrepancy Management, Quarantine, Batch Release, LIMS, 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.
SALARY GRADE: M08/M10
SHIFT: 1 st Shift
Quality Supervisor I- PHD in a Life Sciences or relevant degree with minimal experience. MS in a Life Sciences or relevant degree with minimum of 2 years relevant experience. BS in a Life Sciences or relevant degree with minimum of 4 years relevant experience. An equivalent combination of education and experience may be considered. Excellent communication skills (written and verbal) with familiarity of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Quality Supervisor II- PHD in a Life Sciences or relevant degree with minimum of 2 years relevant experience. MS in a Life Sciences or relevant degree with minimum of 4 years relevant experience. BS in a Life sciences or relevant degree with minimum of 6 years relevant experience. An equivalent combination of education and experience may be considered. Excellent communication skills (written and verbal) with familiarity of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
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.
This position is Employee Referral Bonus Eligible
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 74125
Type: Regular Full-Time
Job Category: Quality