IGIV-C Coordinator (PFF)

Grifols•Clayton, CA

About The Position

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 include, but are not limited to the following: Performs all duties 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 ensure 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 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. 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 and Unicorn control systems, monitor and control the UF/DF process utilizing the DCS and formulation of initial sterile bulks.

Requirements

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
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 be able to lift up to 50 lbs, as well as stand/walk continuously during the shift, and work rotating shifts.
Required vaccination for hepatitis B due to exposure to plasma fractions.

Responsibilities

Performs all duties 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 ensure 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
Monitor buffer usage in process areas and plan buffer makeup as processing defines.
Monitor processing for the Zone 1 operations for consistency.
Independently set up, prepare and operate Zone 2 equipment (includes initial sterile bulk, sterile filter initial and sterile filling bulks).
Independently load and pack the chromatography columns and perform HETP.
Monitor and control the chromatography process utilizing the DCS and Unicorn control systems, monitor and control the UF/DF process utilizing the DCS and formulation of initial sterile bulks.