Are you an experienced Lab Systems Analyst looking for a new role with start up exposure?
Do you have a strong QC background with extensive systems knowledge?
Do you value a good company culture?
If so, I have the role for you.
A Laboratory Business Systems Analyst is required to join a global Biopharma based in Meath. This is for a new lab which will support the manufacturing of enzyme replacement and antibody-based therapies.
The role reports directly into the lab manager however the candidate will work cross functionally and between sites.
The main responsibilities are as follows:
This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa, Waters Empower, Mettler Lab-X. Below activities are associated with these systems;
- Participates in defining user requirements
- Tests and validates the design
- Develops procedures and training documents
- Assist in the implementation at site
- Gather raw data for template building
- After vendor provided training will provide the first line of support within their laboratories
- Empower superuser to build and maintain custom calculation builds and system maintenance
- Reviewing analytical data, analytical reports and performing peer reviews.
- Instrument qualification, maintenance and troubleshooting.
- Protocol generation- method verification/transfer.
- Providing training for team members.
- Following all relevant Standard Operating Procedures.
- Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
- Complies with all pertinent regulatory agency requirements.
- Execution and on-time completion of required training activities.
- Conducts thorough data review to ensure completeness and accuracy of records.
- Reviews test results to ensure compliance with standards; reports any quality anomalies.
- Participates in Laboratory Investigations as required.
- Writes and revises control test procedures and SOPs as required.
- May interact with outside customers or functional peer groups.
- Ensuring self -inspections are performed.
- Ensures new/revised quality system requirements are deployed to the Site.
Education and Experience Requirements
- A Level 8 Bachelor's degree in a technical discipline (e.g. biochemistry, chemistry, engineering etc).
- Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry.
- Excellent communication skills (written and oral).
- An understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Required to work on his/her own initiative in addition to working as part of a team.
- Excellent time management & organisational skills.
- An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis, compendial assays).
- A working understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
- Previous experience with laboratory management systems such as LIMS/ MoDa/ Lab-X and /or Empower systems and interest in coding/ script.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.