JOB DESCRIPTION:

Primary Function

· To ensure the plant meets its customer service, financial, inventory management, quality and safety goals through the timely execution of the Production Schedule.

· To carry out all activities assigned to ensure that production targets in terms of quality, quantity, volume are attained.

Major Responsibilities

· Perform all duties as assigned by Team Leader.

· Carry out operations in the manufacturing area including:

o Manufacturing Processes

o Documentation Practices

o Computer applications e.g. LDRS, DMS, LIMS, ETMS & ERP

o Environmental Monitoring Control Sampling

· Complete and comply with all relevant documentation.

· Adhere to all GMP and GLP requirements.

· Ensure safe work practices and behavior on the job at all times.

· Ensure that activities are completed within budget e.g. waste

levels, per plan requirements.

· Carry out training of new employees as appropriate.

· Support continuous improvement by assisting in and become involved in

Cost-saving ideas & projects.

· Assist in compiling information for annual budgets.

· Maintain adequate stocks of operating supplies and consumables within the laboratory.

· Revising Procedures and other documentation as appropriate.

· Use of computer applications as appropriate.

· Assist in executing validation protocols.

· Maintain ETMS TO DO LIST.

· Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards.

Function Specific Responsibilities

Concentrates:

· Manufacturing of Microparticle and Conjugate components.

· Use of Systems such as AMP’s, MAGSEP, FPLC, Spectrophotometer

· Use of equipment such as stir plates, roller mixers, end over end rotators, pumps and filters.

· Chemical Dispense of material required for manufacturing.

· Adhere to GMP requirements of Class 8 and Class 5 areas and aseptic techniques.

· Perform line clearance as required.

· Adhere to manufacturing formula instruction and procedural requirements.

· Support of any manufacturing activites required by AIDD.

Solutions:

· Manufacturing of Bulk Calibrator, Control, Reagents, Stocks, Buffers and Diluents.

· Large scale batch tank manufacture and smaller scale carboy manufacture.

· Use of equipment such as tanks, stir plates, roller mixers, end over end rotators, pumps, filters and equipments.

· Chemical Dispense of material required for manufacturing.

· Adhere to GMP requirements of Class 8 and Class 5 areas and aseptic techniques.

· Peform line clearnace as required.

· Ahdere to manufacturing formula instruction and procedural requirements.

· Support of any manufacturing activites required by AIDD.

Testing:

· In process testing of Bulk Solutions manufactured at AIDD Longford as per Standard Control Procedure.

· Customer Release Testing of filled vials as per Standard Control Procedure.

· Peform routine maintenance on an operation of ADD analysers eg. Architect and Alinity.

· Execution of In Process Testing through Laboratory Information Management System (LIMS).

· Execution of Testing as required through Instrument Customer Interface as required.

· Non platform testing of AIDD Longford manufactured products including but not limited to HPLC, Lot Uniformity, % solids, LCMS.

· Test Control Procedure Verificaton of generated results through the LIMS system and review and verification of all test results generated at AIDD Longford.

· Initiation, authoring and approval of Laboratory Investigation Reports and Change Requests for instrument flagged errors.

· Execution and Verification of On Market Stability test points as per Standard Control procedure and procedural requirements.

· Execution of Developmental Stability protocols.

· Execution of Complaints and Equas testing requested by the PQA group.

· Support of any testing activities required by AIDD.

Supervisory / Management Responsibility

· Works independently or Individual Contributor.

Education

· The following level of education provides a necessary foundation for this Job function:

· Minimum Leaving Certificate or equivalent plus Certificate in a relevant discipline, as this foundation will provide a basic understanding of the scientific principles required to understand the manufacturing processes and the skills required to record and analyze scientific data.

·

Background

· The following experience provides a necessary foundation for this Job function:

· Previous experience in a scientific manufacturing environment is desirable but not essential. This experience would provide a foundation in the areas of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).

Accountability

· The Diagnostic Technologist must be trained on the relevant procedures and processes before taking responsibility for a manufacturing task. Failure to follow the relevant procedures could result in manufacturing failures or customer complaints and product recalls with the associated financial losses.

· A trained individual is given authority and responsibility to carry out duties without close supervision.

· Formal goals are reviewed on a regular basis and formal performance reviews are carried out.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CRLB Core Lab

        

LOCATION:

Ireland > Longford : Lisnamuck

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Lf5Desg1 (Ireland)

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable