Reagent Fill Tech IV - Machine Operator - Automated Filling - 2nd Shift - Variable Shift 525980
Reagent Fill Tech IV - Machine Operator - Automated Filling - 2nd Shift - Variable Shift 525980
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.
Grifols Diagnostic Solutions Inc is seeking a Reagent Fill Technician IV to support Grifols Diagnostics Blood Typing Solutions Manufacturing. The Reagent Fill Technician IV will be responsible for performing manufacturing and assembly of clinical and commercial products. Weighs measures and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities. Participates in the filling aliquoting and packaging of bulk material into the final product. The Reagent Fill Technician IV will be responsible for working with our automated fill machines labelers reading expected units at the end of shifts assembling ceramic pumps adjusting pumps and filling volumes.
To succeed in this role we are seeking candidates to have at least an Associates Degree in Biology Mechanics Engineering or related field. With 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment.7 years minimum experience in a lab setting is highly preferred. Individuals with experience in microliters sealing process (with temperature and time) Vision Systems familiar with cleaning process (cleaning pumps and operating autoclave washers) are preferred.
Shift Requirement: Variable Shift
Responsibilities
- Handling and traying of temperaturesensitive (semi)finished goods for use in blood typing kits
- Perform in process visual inspection of temperaturesensitive (semi)finished goods for use in blood typing kits as they come off the fill line before placement in trays.
- Perform sample gathering of temperaturesensitive (semi)finished goods for use in blood typing kits for QC and Bioburden.
- Receives and verifies the accuracy of materials transferred from the warehouse.
- Assists with material handling folding product boxes/trays and staging of materials for process orders
- Understands and executes written procedures in accordance with cGMP.
- Performs labor transactions in the Enterprise Resource Planning (ERP) System.
- Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review.
- General manufacturing area housekeeping including cleaning of labware equipment totes shelves benches and sinks and removing trash.
- Ensures proper transportation handling and disposal of hazardous biohazardous and/or infectious substances.
- Maintains accurate and complete training records.
- Maintains and archives Manufacturing log sheet records.
- Demonstrate processes during audits including ISO FDA and internal audits.
- Follows all safety rules.
- Must be able to communicate product issues safety incidences and/or personal issues affecting production timelines.
- Independently perform and lead the setup and operation of reagent filling equipment of at least 90 of automated fill machines.
- Primary contact for material transfer delegation
- Implement new areas or ideas for 5S
- Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation
- Act as mentor and train Reagent Fill Technician I Reagent Fill Technician II and Reagent Fill Technician III
- Lead equipment troubleshooting during the setup change over and operation to ensure completion within the scheduled time frame.
- Performs device history record review release and collaborates with Quality Assurance on any outstanding issues
- Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP)
- Work in crossfunctional teams to lead process improvement projects within the filling department
- Responsible for printing and distributing the cycle count forms gathering and reviewing the completed forms and investigating discrepancies
- Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation
Additional Responsibilities
Crossfunctional communication participation. Assists packaging crew as needed. Responsible for flushing water ports and eyewash stations. Adhere to target manufacturing timelines. Punctuality and attendance are required. Attentiveness and openness to learn new processes. Performs refrigerator/freezer maintenance. May crosstrain in other areas of manufacturing and operations based on business need. May mentor and help train Reagent Fill Technican I II and III. Assist with Device History Record (DHR) review. May be responsible for demonstrating manufacturing processes during a customer or regulatory audit. Initiate Quality Notifications (QN). Act as rework coordinator. Initiate lab walkthrough for audit preparation.
Knowledge Skills and Abilities
Demonstrated job specific technical knowledge. Intermediate knowledge of laboratory safety and record keeping. Working knowledge of GDP GMP and ISO Reg. Blood Borne Pathogen Training. Advanced knowledge of Microsoft Office software. Attention to detail good organizational skills and team oriented. Ability to follow oral and written instructions. Intermediate knowledge of laboratory science procedures techniques instruments & equipment. Ability to effectively communicate with team members and crossfunctional departments.
Education:
Requires Associates Degree in Biology Mechanics Engineering or related field.
Experience:
6 years minimum experience as a reagent fill technician or equivalent in a regulated setting.
2 years experience troubleshooting fill equipment.
7 years minimum experience in a lab setting is highly preferred.
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 an Associates degree plus 2 years of experience an equivalent could include 4 years of experience or a Bachelors degree.
Occupational Demands:
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Visually inspect components and final kits for compliance and specifications. Close vision 20 inches or less) will be utilized and some color identification will be required. Frequently required to stand sit use hands/fingers to handle or feel perform reaching bending stooping or kneeling motions. Operators may be required to walk for a considerable amount of time. May occasionally lift carry push pull or otherwise manipulate objects up to 40 pounds in weight. Will be required to frequently or continuously lift carry push pull or otherwise manipulate objects up to 10 pounds in weight. May move heavier (greater than 50 pounds) objects and/or materials using carts or pallet jacks. The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs.
PayScale
The estimated pay scale for this Reagent Fill Technician IV role based in San Diego California is $30.30 to $37.87 per hour. Additionally the position is eligible to participate in up to 5 of the company bonus pool. We offer a wide variety of benefits including but not limited to: Medical Dental Vision PTO up to 5 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education experience skillset knowledge where the role is performed internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its familylike culture. Our company has more than tripled over the last 10 years and you can grow with us!
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 : CASan Diego:USSDW San Diego CA Willow Ct Mfg
Required Experience:
Unclear Seniority
Employment Type
Full-Time
