BioManufacturing Associate - Room for Advancement

Job Details:
Reagent Fill Tech II in San Diego, CA
06 Months Contract to Hire
Shift: 1st Shift - 7 am-3:30pmPST

Top 5 Things:

• Understand how to use ERP systems
• 2 years minimum experience as a reagent fill technician or equivalent in a regulated setting
• 3 years minimum experience in a lab setting is highly preferred
• Experience in mentoring and helping train  new Reagent Fill Technician

Job Description:

Job Summary: 
Responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to ensure 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 an in-process 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 33% of automated fill machines. -Performs material and labor transactions in the Enterprise Resource Planning (ERP) System. -Perform basic troubleshooting activities to ensure continued operation of the fill machines. -Participate in process improvement projects from inception to completion -Identify new opportunities for 5S -Verify or perform cycle counts and verify discrepancy, conduct investigation and complete report to notify lead 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 Technician I. Knowledge Skills and Abilities: -Demonstrated job-specific technical knowledge. -Working knowledge of laboratory safety and record keeping. -Working knowledge of GDP, GMP and ISO Reg. -Blood Borne Pathogen Training. -Intermediate knowledge of Microsoft Office software. -Attention to detail, good organizational skills, and team-oriented. -Ability to follow oral and written instructions. -Basic knowledge of laboratory science, procedures, techniques, instruments & equipment.

Education: 
Requires High School Diploma or GED Experience: 2 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 3 years minimum experience in a lab setting is highly preferred. Knowledge of mechanics or engineering desired.

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.