IGIV-C Coordinator

1 month ago


Clayton, United States GRIFOLS, S.A. Full time

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.

Schedule: 12 Hours Rotating Shift

IGIV-C Coordinator:

The IGIV-C Coordinator is responsible for the isolation of IgG by processing plasma intermediate paste and performing complex tasks within a GMP environment by cleaning and maintaining the workplace, cleaning, assembling and disassembling operating equipment per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.

Primary responsibilities for role:
•Performs all duties as described at the IGIV-C Sr. Technician level.
•Assists the supervisor in conducting shift operations which includes scheduling of personnel and ensuring that activities are being performed on schedule, safely and in GMP compliance;
•Recognizes issues which can be dealt with and resolved during the shift and deal with those.
•Recognizes issues which require higher level input to resolve, communicates them effectively and takes appropriate measures to deal with them.
•Informs the Supervisor about production status, problems, etc.
•Monitors area to insure that personnel are operating per all procedure and guideline standards.
•Ensures the facility is at appropriate level of maintenance and follows up on work orders to provide a safe work environment.
•Assists supervisor in checking over BPR's and making appropriate BPR changes.
•Integrates new employees and ensures process training for new employees is completed as required.
•Works with the Supervisor to maintain yields and meet production schedules.
•Provides input to the Supervisor regarding individual performance of team members.
•Coordinates the use of production equipment to maximize capacity.

Additional Responsibilities:

Buffer Prep: Monitor buffer usage in process areas and plan buffer makeup as processing defines. Zone 1: Monitor processing for the Zone 1 operations for consistency.

Zone 2 Sterile Processing: Independently set up, prepare and operate Zone 2 equipment (includes initial sterile bulk, sterile filter initial and sterile filling bulks).

Column Processing: Independently load and pack the chromatography columns and perform HETP. UF/DF Processing: Monitor and control the chromatography process utilizing the DCS control systems, monitor and control the UF/DF process utilizing the DCS and formulation of initial sterile bulks.

Must have demonstrated the ability to lead others, organize and schedule activities, effectively communicate with others, prepare written documents, understand the process and control systems. Must have demonstrated a commitment to GMP, safety and care of the product and facility. Must have aptitude for math, demonstrated exceptional technical know-how, ability to troubleshoot and ability to train others. Employee must also be proficient in at least 4 of the Process Areas listed above. Demonstrated ability to train less experienced personnel.

Requirements:

Present or past production work experience in IGIV-C Department. Employee must meet all requirements for the IGIV-C Technician III level position and must have received a minimum of a meets expectations overall rating on his/her most recent performance review. Employee must also be proficient in at least 4 of the Process Areas listed above. Demonstrated ability to train less experienced personnel.

Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment and moving machinery. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32*. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed standing, walking and bending neck for 6-8 hours per day. Frequently sits for 4-6 hours per day. Frequent 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. Occasionally bends and twists neck and waist. Light lifting of 15lbs for 2-4 hours per day with a maximum lift of 50lbs. Hearing acuity essential. Color perception/discrimination, and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 performs routine tasks by following a set of written or oral instructions/procedures.

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 in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

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