Grifols Jobs

Job Information

Grifols Shared Services North America, Inc Reagent Fill Technician Lead in San Diego, California

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 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. Leads a team of direct reports, within the department including coaching, settting goals and expectations. Is responsible for ensuring that the designated fill labs utilized to produce completed filled reagents are maintained.

Primary responsibilities for role:

  • Leads a team of direct reports, within the department including coaching, reviews and identification of talent.

  • Oversee daily production processes and ensure all activities are completed in compliance with current GMPs and regulations.

  • Monitor process set-ups and run times for adherence to the manufacturing schedule

  • Lead team meetings, including daily morning team meeting

  • Attend cross-functional meetings

  • Device History Record (DHR) Review: Document review, SAP transfer review, variance review and submission to quality

  • Investigate variance discrepancies for completed process orders against the scheduled cost, hours and material quantity

  • Responsible for reviewing schedule to maximize efficiency and assign personnel to production orders

  • Real time response to production non-conformances, escalation of information to the appropriate cross-functional team and execute action items to ensure resolution

  • Track performance metrics and Key Performance Indicators (KPIs) to drive continuous improvement

  • Conduct one on one meetings with team members to facilitate coaching

  • Responsible for maintaining the team training matrix

  • Scrap coordinator responsible for identifying, monitoring and delegating to minimize scrap

  • Initiate and perform quality notification investigations

  • Support in the preparation and provide subject matter expertise for regulatory audits (e.g., internal, notified body, regulatory authorities).

  • Handling and traying of temperature-sensitive (semi-)finished goods for use in blood screening kits

  • Perform inprocess visual inspection of temperature-sensitive (semi-)finished goods for use in blood screening kits as they come off the fill line before placement in trays.

  • Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood screening kits for QC and Bio-burden.

  • 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 accurate and complete training records.

  • 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 set-up and operation of reagent filling equipment of at least 90% of automated fill machines.

  • Primary contact for material transfer delegation

  • 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 set-up, change over and operation to ensure completion within the scheduled time frame.

  • Work in cross-functional 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

Additional Responsibilities:

Cross-functional 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 cross-train in other areas of manufacturing and operations based on business need. May mentor and help train Reagent Fill Technician I, II and III. 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. Final approver for archived documents. Cycle count approver. Assist with transfer of products and processes into manufacturing. Proactively identifies any issues that impacts overall production and determine possible solutions and collaborates with management.

Knowledge, Skills and Abilities:

Demonstrated job specific technical knowledge. Advanced knowledge of laboratory safety and record keeping. Advanced 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. Advanced knowledge of laboratory science, procedures, techniques, instruments & equipment. Strong leadership skills, demonstrated by guiding project teams. Strong written and verbal communication skills. In-depth knowledge of filling processes and concepts.

Education:

Requires Bachelors Degree in Biology, Mechanics, Engineering or related field.

Experience:

8 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment. Prior leadership experience preferred. 10 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 typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor’s 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.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 421387

DirectEmployers