Job Title: Reagent Manufacturing Associate
Company: Luminex Corporation
Location: Madison, WI
Job Type: Full-Time
The Luminex Corporation seeks a Reagent Manufacturing Associate for its Madison, WI office.
The Reagent Manufacturing Associate assists with duties that span a broad range of activities within the manufacturing operations at Luminex. The Reagent Manufacturing Associate is primarily responsible for delivering manufacturing requirements against production schedule within a focused manufacturing operation and/or product segment. The Reagent Manufacturing Associate also participates in manufacturing processes to support new product design transfer, stability program, process development, equipment validations, process validations, and investigations and resolution of product/process issues. The position is responsible for performing maintenance and calibration of Manufacturing measuring and monitoring devices as well as maintaining the integrity of work areas.
Manufacturing environment is a high complexity, small/large run production environment. The site is responsible for standard and custom Luminex reagent product lines encompassing Molecular Diagnostic products. Organization is ISO 13485:2003 certified and includes products that are FDA regulated.
• Deliver manufacturing requirements and attainment of production schedule for standard inventory, build-to-order, and contract manufacture market products
• Deliver manufacturing requirements for qualification/processing of incoming materials, production intermediates, and stability samples
• Deliver timely and accurate completion of manufacturing sections of process documentation and related business system transactions
• Manufacture of finished goods and in-process reagents under approved documentation
• Deliver timely and accurate completion of inventory cycle counts
• Document non-conformances
• Support design transfer and integration of new products and processes
• Support process development and process improvement projects
• Support investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation
• Deliver timely maintenance and calibration of assigned Manufacturing measuring and monitoring devices
• Monitor select non-inventory supplies, maintain focused supplies, and generate purchase requisitions as needed.
• Maintain cleanliness and integrity of manufacturing laboratory and storage areas
• Participate in applicable departmental and interdepartmental training; maintain current and effective training to standard operating procedures, work instructions, and applicable changes affecting the Reagent Manufacturing.
• Assist in establishing annual performance goals; fulfill performance goals
• Maintain effective and professional multi-level organizational interfaces.
• Maintain personal compliance and facilitate departmental compliance with the Quality System.
• Adhere to safety, disposal, and gowning requirements
• Accurately complete all required documentation for production of quality controlled products including the use and calibration of laboratory equipment and laboratory notebooks for process development projects.
• Other related duties as assigned.
• Learning on the Fly- learns quickly/open to change
• Organizational Agility – knows how to go through the proper channels to get things done
• Peer Relationship – cooperative, team player, trusted and supported by peers
• Planning- sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
• Priority Setting – focuses on what is most important
• Written Communications- effectively communicates in writing
• Minimum Associate’s degree in chemistry, biochemistry or biological/natural sciences or more than 4 years related experience and/or training
Required Certifications/License/Special Skills:
• Highly organized with proven time management and prioritization skills
• High degree of attention to detail
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines
• Excellent interpersonal, verbal and written communication skills
Required Work Experience:
• Experience with equipment and data analysis methods used in a chemistry laboratory
• Experience with calibrated balances, pH meters
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Experience in a GMP and/or FDA regulated environment is preferred
• Must work onsite at Luminex office 90% of the time
• Travel may be required approximately: 0% of the time. No travel is required.
• Possible exposure to biological or chemical hazard
• Work situations include dealing with people; working alone; and making judgments and decisions
• Lifting/Use of Strength is Medium (20 to 50 pounds)
• Climbing on the job is required: Occasionally– up to 33% of the time
• Kneeling on the job is required: Occasionally — up to 33% of the time
• Reaching on the job is required: Occasionally — up to 33% of the time
• Stooping on the job is required: Occasionally — up to 33% of the time
• Vision (Color) on the job is required: — up to 33% of the time
To apply online, please click here.
An equal opportunity employer, M/F/D/V.
Please reference BioTechPharmJobs.com when responding.