Pomona, CA, USA
ROLE AND RESPONSIBILITIES •
Perform assembly of diagnostic kits, Quantisal, microplates and finished product components per schedule given by the Manufacturing Manager and/or Supervisor Perform • Document production of diagnostic kits, Quantisal, microplates and finished product components on proper batch record and bill of materials • Record manufacturing activities in production log, maintenance log and MasterFlex calibration log • Perform required calibration of manufacturing equipment before use • Perform manufacturing line clearance before production • Perform different stages of microplate coating • Review all labeling information prior to production • Perform weight and volume measurements • Perform all activities according to Manufacturing Batch Record and Standard Operating Procedures • Perform routine equipment maintenance and limited troubleshooting activities as required • Responsible for manufacturing quality products efficiently, accurately, safely and on time • Utilize manufacturing equipment to manufacture products in accordance to current Good Manufacturing Practices (cGMP), company policy and safety regulations • Provide general support to the manufacturing team • Maintain a clean and safe work area • Follow all safety guidelines and report unsafe conditions to supervisor • Relate to team members, supervisor and manager in an ethical manner
QUALIFICATIONS AND EDUCATION REQUIREMENTS •
Medical device manufacturing experience • Demonstrate literacy and comprehension of technical documents such as batch records, labeling, product inserts, and standard operating procedures. • Basic math skills with the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to add and subtract two digit numbers and to multiply and divide with 10's and 100's. • High school diploma or equivalent, may be substituted for manufacturing experience
PREFERRED SKILLS •
Spanish bilingual • Knowledge of GMP and International Standards (ISO) guidelines
Pomona, CA, USA
Role and Responsibilities
Independently sets priorities and accomplishes objectives in the support of department through activities such as the planning and/or sourcing of manufacturing, maintenance of raw material inventories and monitoring of work in progress, management of finished goods inventories, and provision of ongoing and varied assistance to production
Assist daily operational functions of planning and scheduling production
Conduct root cause analysis to reconcile operational gaps and make recommendations based upon findings as well as production environment
Responsible for appropriate departmental documentation and maintains information in appropriate systems
Responsible for recommending, specifying, implementing, creating, maintaining, interpreting, improving, summarizing and reporting on the performance indicators for production
Compiles detailed information including routine analysis, to assist in forecasting, the assessment/control of manufacturing processes, and evaluation of vendor performance, etc.
Collaborate across departments to help team achieve departmental targets
Actively participates in departmental programs and continuous improvement efforts
Planning and/or forecasting within an ERP system
Understanding manufacturing environment, planning and scheduling procedures, statistical analysis, forecasting principles and techniques required
Knowledge of supply chain, manufacturing, costs and other business skill sets
Knowledge of business and management principles involved in strategic planning, resource allocation, and production methods
Problem-solving skills to gather relevant information to solve less well-defined practical problems
Functional knowledge of Manufacturing and Distribution
Ability to work in a team environment, create and execute project plans and complete projects on schedule
Review/Manage Sales Order backorders
Monitor transactions in/out of inventory
Research/resolve inventory discrepancies, short shipments and miscellaneous emergent issues
Proficient user of Manufacturing ERP/MRP system views Manufacturing, Parts, Sales Orders, Backlog, Vendor info, BOMS, and Inventory details
Assist management to coordinate, facilitate and reconcile inventory discrepancies and adjustments during companywide inventories.
Trained in ISO: 13485:2003 or ISO: 9001 Quality Management Systems.
Managed custom Sales Order process from receipt of order to customer delivery and acceptance.
Provide communication between Manufacturing Manager and production/shipping/office personnel
Attend manufacturing meetings along with Manufacturing Team Leaders, Supervisors and Manager
Resolve problems as they develop and communicate them to the Manufacturing Manager
Develops and recommends improvements of procedures to improve safety, quality, and efficiency
Relate to all manufacturing personnel in an ethical manner
Maintain adherence to company policies, safety standards, and good manufacturing practices (GMP)
Conduct, lead, or implement the appropriate process audits; the audits will identify the need for the appropriate containment, corrective, and preventive actions, leading to minimizing or eliminating process deviations and non-conforming product root causes.
$21.00 - $27.00 hourly
Pomona, CA, USA
Under direct supervision, the scope of this position is responsible for maintenance items, installations and general repairs.
Tasks and responsibilities:
Conduct minor maintenance and repair on all areas of the facility; including, but not limited to: flooring, wall patch, painting, plumbing, lighting, ceiling, tile, doors, etc.
Electrical installations and wiring.
Plumbing installations and piping.
Flooring patches and repairs for sheet vinyl and VCT.
On-site escort of contractors and vendors.
Installation of minor equipment.
Organize and direct small projects and minor build outs not requiring the services of a general contractor.
Assist with HVAC maintenance and troubleshooting.
Assist Facilities Technician I; may be asked to train and/or mentor.
Carry out various tasks with site security systems such as conducting security badging; maintain security access control, and CCTV systems.
Minor moving of furniture and conference room setup.
On-call responder for alarm calls, 24/7 coverage.
Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR.
Carries out duties in compliance with established business policies.
Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Perform other duties & projects as assigned.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Preferred educational background:
High School diploma or equivalent. Trade school preferred.
Three to five years maintenance experience preferably in medical or health related environment.
General carpentry, electrical, HVAC, flooring and plumbing skills required.
Able to work with a variety of people on multiple tasks.
Strong oral and written communication skills.
Adaptable and willing to take on multiple new tasks and responsibilities.
Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time.
Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives.
Computer literacy; including MS Office.
Full benefits, retirement, and 3 weeks vacation!