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Lauridsen Group Inc. Production Operator- Night Shift- Biologicals in Boone, Iowa

Job Description:

The purpose of this job is to assist in the efficient fractionation of bovine plasma into high purity scientific products for the diagnostic, pharmaceutical and research markets in compliance with FDA, USDA, and OSHA regulations.

JOB QUALIFICATIONS:

Education:

High School Diploma or GED required

Experience:

Experience in biological production or manufacturing preferred.

JOB DUTIES:

  • Operate computer-controlled equipment and numerical control devices.

  • Ability to assist in trouble shooting and correction of malfunctions as they are encountered during bioprocessing operations.

  • Actual operation (hands on) time with these devices approximately 75% of time.

  • Assist in the control and monitor centrifuge, filtration system, liquid handling devices, environmental/temperature control systems.

  • Perform necessary testing as described in the laboratory testing section below and complete the necessary calculations to adjust the bioprocess equipment.

  • Follow GMP Standard Operating Procedures for production of product and maintenance of a controlled, aseptic manufacturing environment.

  • Understanding of basic FDA and USDA regulatory requirements as they relate to the processing and testing of the biologicals products.

  • Assist in the maintenance of the necessary documentation to ensure compliance with regulatory requirements in bioprocessing operations.

  • Assist in the performance of laboratory testing during bioprocessing. This will include:

  • Analysis of protein content by Cobas methodology.

  • Performance of solids testing, by centrifugation and gravimetric methodology.

  • Determination of conductivity.

  • Determination of pH.

  • Test for Non-Volatile Residues (NVRs – Solids/Ash).

  • Perform freeze-thaw testing.

  • Evaluation of clarity.

  • Temperature control operations.

  • Perform calculations necessary to effectively and efficiently produce intermediate and finished products with centrifugation and filtration bioprocesses.

  • Accurately perform record keeping tasks and perform math and chemistry calculations according to established procedures.

  • Support Production Lead Operators and Shift Supervisors in performance of their duties and improvement of bioprocessing operations.

  • Ensure accurate observation and analytical analysis of operations and test results.

  • Assist in the maintenance of records and evaluation of data that permits the analysis of production efficiencies.

  • Maintain a clean, aseptic manufacturing environment by performing routine cleaning of the manufacturing facility and preventative cleaning/maintenance on equipment.

  • Fill - Weigh – sift, package, tie seal and/or palletize containers for customer orders.

  • Insure that all containers are properly labeled and controlled according to regulatory and corporate guidelines.

  • Maintain the segregation of materials according to their status during in-process and finished product stages of the operation, i.e. accepted, rejected, in-process, quarantined, and released.

  • Sample and submit product for final analysis by QA using established sanitary methods and procedures.

  • Ability to track samples in testing process.

  • Ability to coordinate activities with QA laboratory to insure timely testing and results generation.

  • Operate company vehicle and forklift as required.

JOB REQUIREMENTS:

  • High-school-level knowledge of biology and biochemistry; familiarity/training in bioprocessing.

  • Ability to handle materials in accordance with Standard Operating Procedures.

  • Ability to learn and work under Bulk Pharmaceutical Chemical Good Manufacturing Practices with established procedures and detailed documentation requirements.

  • Ability to learn and safely operate various types of scientific and computerized equipment/machinery required in job duties.

  • Ability to interpret and work from oral and written instructions.

  • Ability to occasionally operate forklift and/or pallet jacks and to drive a vehicle and maintain valid driver’s license.

  • High-school level math and chemistry skills.

  • Ability to move freely throughout the bioprocessing area.

  • Ability to legibly document data for record-keeping purposes.

  • Ability to communicate effectively with Proliant Biologicals personnel.

  • Ability to remain calm and professional.

  • Ability to read, write, and comprehend instructions related to liquid fractionation, separation, concentration, filtration, centrifugation and other related duties.

  • Knowledge of organizational methods and the ability to manage multiple tasks/projects simultaneously.

  • Ability to operate all necessary plant and office equipment required to accomplish job duties, such as computers and office telephones.

  • Ability to work daily, weekends and extended hours as necessary.

  • Ability to assist other work-related areas, as required.

  • Ability to learn and operate windows environment software, such as Microsoft Word.

BASIC PHYSICAL REQUIREMENTS:

Approximate: 12-Hour Day (may be longer or require flexibility to accommodate production schedule)

Key:

Occasional = 0% - 33%

Frequent = 34% - 66%

Continuous = 67% - 100%

N/A = Not Applicable

Standing - Continuous

Sitting - Occasional

Walking - Frequent

Bending/Kneeling/Crouching/Stooping - Frequent

Reaching Above Shoulder - Frequent

Climbing (stairs, ladders, etc.) - Frequent

Working on Heights:

Unprotected Heights - Occasional

Protected Heights - Frequent

Lifting Weights from 0 to 60 pounds - Frequent

Push/Pull/Maneuver Equipment/Products/Materials

Weighing from 0 to 2,000 pounds - Frequent

Being Around and/or Operating Moving Machinery/Equipment - Frequent

Operating a Forklift (as a part of your job) - Frequent

Read/Monitor Gauges on Various Equipment/Machinery - Frequent

Hand Movements:

Recording Data - Frequent

Operating Office Equipment - Occasional

Operating Computer - Frequent

Simple Grasping (right and left) - Frequent

Firm Grasping (right and left) - Frequent

Fine Manipulating (right and left) - Occasional

Foot Movements to Operate Foot Controls - Occasional

Good Vision, Corrected to Normal; or Ability to Access

Required Information and to Perform Job Duties - Yes

Color Definition - Yes

Good Hearing, Corrected to Normal; or Ability to Communicate

and/or Understand Required Information and to Perform Job Duties - Yes

Ability to be Mobile throughout Required Work Areas

Office - Occasional

Multiple Locations - Occasional

Plant - Continuous

Equipment/Maintenance or Repair Area - Frequent

Rough Terrain - N/A

Other - N/A

Office/Desk - Occasional

SAFETY RESPONSIBILITIES AND REQUIREMENTS:

The Production Operators are required to follow all safety policies and procedures. Job duties include maintaining good housekeeping throughout the facility, using required personal protective equipment and recognizing the hazards of the job and taking precautions to assure safety to themselves and others. Responsibilities include always applying safe work practices, informing their supervisor of hazards

BASIC MENTAL REQUIREMENTS:

This job requires the mental capabilities to understand job functions, Standard Operating Procedures and safety procedures as required by job duties. The employee must be able to understand and follow established procedures for fractionation, separation, liquid handling, process and personnel flow, and be able to adhere to Standard Operating Procedures without deviation. Understanding of written/oral instruction, record data, communicate with co-workers, and perform high-school level math and chemistry calculations and understand basic scientific principles is a must.

WORKING CONDITIONS AND EXPOSURES:

Working conditions vary, the major portion of the job duties occur in a controlled-temperature indoor environment (60-70 degrees Fahrenheit) in a manufacturing process area, including product handling, packaging and equipment cleaning materials. The manufacturing floor has controlled access, lab coats or uniforms and aseptic requirements (hairnets, shoe covers, gloves as necessary). There will be exposure to many different chemicals used during processing and clean up, high noise levels, moving machinery/equipment, climbing on heights, moving throughout the building to different processing areas, some exposure to splashing liquids and dust, and concrete floors. May be required to operate computer, copier, printer, and fax machines as necessary.

LGI’s foundation began in 1916 as the Lauridsen Creamery, selling butter, eggs and poultry to the local community. Although our headquarters in Ankeny, Iowa, is not far from the old creamery in Dedham, Iowa, the company is now worldwide with more than fifty manufacturing and sales locations in twenty countries and sales in more than sixty countries.

Each company under the LGI umbrella is truly independent. They have the ability and the charge to be entrepreneurial, to seek out new markets, to develop new products and applications, and – above all - to discover new ways to add value through fractionation and novel application.

What’s more, because some LGI companies have offices and presence around the world, all LGI companies benefit from their exposure to new markets, new products, new applications and new thinking.

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