Gena Monroy

As a Senior Lyophilization Mechanic, you will be the senior refrigeration mechanic responsible for a fleet of nine production lyophilizers and one pilot-scale freeze-dryer. Working as a team with a second mechanic and authorized service agents, this candidate will perform preventive maintenance and unscheduled repairs, maintain critical spare-parts inventory levels, and provide on-call, after-hours technical support to the production staff. Emergency callbacks in the event of equipment downtime are mandatory.  

How You'll Make An Impact:

• Maintain world-class OEE performance.

• Partner with Engineering to continuously improve the Lyophilization Program at QSD Irvine.

• Address obsolescence with creative solutions that drive reliability and efficiencies.

• Support production to ensure customer demand forecasts are met and delivered.

• Ensure Irvine remains a “Center of Excellence” for lyophilization capabilities within the Bio-Rad Organization.??

 What You Bring: 

• High School Diploma or equivalent.

• Refrigeration certification with demonstrated experience in lyophilization.

• Hands-on mechanical troubleshooting and repairs of freeze-dryers. Manufacturing experience a plus.

• Demonstrated mastery of Compressor replacement, txv replacement and tuning, diaphragm valve rebuilds, refrigerant handling and conservation, welding and brazing, leak detection is essential.

• Experience with cGMP Documentation requirements.

• Pharma, medtech, biologics industry experience essential.

Job Title: Regulatory Affairs Specialist 

Pay Range: $40

Work Schedule: Hybrid after 30 days Monday and Tuesdays on site, the third day candidate’s choice. 8:00am to 4:30pm 

• Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
• Ability to communicate effectively with employees across multiple departments
• Highly organized and detail-oriented. Good time management.
• Technical aptitude for understanding IVD product features
• Understanding of databases and electronic systems.

• Education: BS in Biology or other scientific field
• Work Experience: 0-2 year’s experience in IVD regulatory affairs.
• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
• Laboratory research experience in an IVD medical device regulated environment is strongly preferred.
• Understanding of scientific reports, risk management, Quality Systems

• Handle and direct all incoming customer calls and inquiries with professionalism.
• Accurately enter customer orders into the company's order processing system.
• Provide timely and effective responses to customer questions and requests.
• Track production and assembly progress to ensure on-time delivery.
• Expedite orders as needed to meet committed delivery dates.
• Process customer change orders in a timely and accurate manner.
• Collaborate with the Production Scheduler to maintain delivery performance.
• Prepare and issue routine price quotes as required.
• Work cross-functionally with internal teams to identify and resolve issues.
• Review and evaluate new customer or molding inquiries, forwarding them to the appropriate manager.
• Provide general administrative support including answering phones, scanning documents, and maintaining organized customer records.
• Serve as the primary coordinator for customer complaints and Returned Material Authorizations (RMAs).
• Support the Document Control team by processing Engineering Change Notices (ECNs).
• Ensure compliance with quality standards and regulations, including ISO 9001, AS9100, ISO 13485, GMP, ITAR, and JG Plastics safety protocols

• Prior experience in a manufacturing environment is required, with strong preference given to candidates with injection molding experience.
• Energetic, self-driven, and detail-oriented, with a strong ability to work collaboratively in a team setting.
• Professional and friendly phone demeanor with clear, articulate communication skills.
• Enjoys direct customer interaction and demonstrates the ability to foster positive, long-term customer relationships.
• Consistently exhibits a courteous, helpful, and customer-focused attitude.
• Strong organizational skills with a proven ability to manage follow-up tasks and maintain effective systems.
• Proficient in typing and general computer use necessary for customer service duties.
• Ability to quickly learn and understand customer products and service requirements.
• Demonstrated commitment to delivering exceptional customer service and acting as a customer advocate.
• Excellent interpersonal and communication skills for effective collaboration with both customers and internal teams.
• Experience with ERP/MRP systems required; familiarity with IQMS is highly preferred.

Job Title: Receiving Clerk with Reach Truck Driver Experience

• Receiving and labeling product
• Prepare products to be received or shipped
• Match actual product to associated documentation, record transactions, print labels and distribute products to designated departments
• Prepare daily paperwork to send to the accounting department
• Perform work safely and in accordance with company safety standards and regulations
• Maintain cleanliness in receiving areas
• Performs other duties as assigned.

• 2-5 years of previous receiving experience
• Reach Truck Driver experience
• Strong attention to detail
• Ability to prioritize and multitask
• Must be able to read, write and speak Spanish/English
• Experience operating heavy machinery, such as cherry picker and reach truck
• Ability to lift 25 pounds or more, as needed
• Ability to work extended hours and weekends

If you believe you are a qualified candidate for our Receiving Clerk, please click apply below to apply on our website!

Job Title: 1st Shift Picker

• Pulls and packs products based on daily orders.
• Meets specifics of customer orders in a timely manner.
• Keeps products separated, organized and in good rotation.
• Monitors product quality frequently, reporting problems to mitigate safety issues.
• Use RF Scanner to check inventory into the WMS system (Warehouse Management Software)

1st Shift Picker job requirements:

• 1+ years of picking experience in a fulfillment warehouse
• Must be able to read, write and speak Spanish/English
• 2+ years of RF scanner experience
• Computer skills
• Previous experience within the apparel experience is required
• Must be able to stand for long periods of time
• Dependable, punctual, organized, team player attitude

If you believe you are a qualified candidate for our 1st Shift Picker position please click apply below to apply on our website!

Job Title: Part time Payroll Clerk (Immediate Need)

• Maintain payroll information by collating, calculating and entering data
• Update payroll records by entering any changes to employee information or benefits such as job title changes, exemptions and saving deductions
• Resolve payroll discrepancies and answering any employee payroll queries

• The ideal candidates will have 2+ years of payroll experience
• Previous experience using Paylocity payroll system, required
• Effective communication skills
• Strong attention to details

Job Title: Packager

• Pack merchandise that has been pulled off the shelves to fulfill customer orders.
• Accurately package, label, print invoice, and weigh items to be shipped to ensure proper shipment method and shipping charges.
• Scan, sort, and stock new merchandise to inventory shelves.
• Maintain a clean and neat working station (includes, sanitizing all touch points of the workstation)

Packager job requirements:

• 1+ year packaging experience within an warehouse environment
• Must have experience in the apparel industry
• Must be able to stand for long periods of time
• Must be able to read, write and speak Spanish/English
• Must have basic computer skills
• Must be able to work in a fast-paced environment w/ demonstrated ability to juggle multiple tasks
• Dependable, Team player

If you believe you are a qualified candidate for our Packager, please click apply below to apply on our website!

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