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Reagent Fill Technician IV
10808 Willow Court San Diego, CA 92127 US
Job Description
Target PR: 32/hr
*Based on experience
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. Participates in the filling, aliquoting, and packaging of bulk material into the final product.
Primary Responsibilities:
- 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 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, bio-hazardous 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 set-up 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 set-up, change over and operation to ensure completion within the scheduled time frame.
- Performs device history record review release and collaborates with Quality Assuance on any outstanding issues
- Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP) ·
- 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 needs.
- May mentor and help train Reagent Fill Technicians 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.
- Requires Associates Degree in Biology, Mechanics, Engineering or related field.
- 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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