Job Title: QC BioAnalytical Sciences - Senior Associate
*Candidates need full long-term Irish working rights, no sponsorship provided*
Position Overview
This position outlines the general responsibilities associated with the role of QC BioAnalytical Sciences - Senior Associate at our manufacturing facility. The successful candidate will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to laboratory operations and compliance with minimal supervision, acting as a role model for other laboratory colleagues.
The role involves implementing continuous improvement projects and supporting a lean laboratory culture focused on Right First Time (RFT) initiatives. Additionally, the Senior Associate represents the QC unit by liaising with both internal and external stakeholders.
The role may also involve carrying out additional work functions associated with the position that are not explicitly described in this specification.
Key Responsibilities
- Analytical Expertise: Demonstrate experience in a wide variety of analytical techniques including, but not limited to, cell-based Bioassays, Immunoassays, Cell Culture (specifically for the execution of bioassays), and Aseptic Technique. Experience with liquid-handling robots is highly preferable.
- Testing & Execution: Plan and perform multiple, complex routine and non-routine methods, procedures, and a large variety of assays.
- Data Review: Participate in the peer review of analytical data.
- Technical Leadership: Responsible for providing technical guidance, applying expertise, and utilizing critical thinking to help resolve complex technical issues.
- Training: Lead the training of laboratory staff on technical aspects of the job as required.
- SOPs & Documentation: Participate in the generation, update, and revision of Standard Operating Procedures (SOPs), trend data, investigations, non-conformances, validation protocols, reports, and method validation/verifications. Develop and implement procedures that comply with appropriate regulatory requirements.
- Equipment & Method Transfers: Lead and support the qualification of analytical equipment and related testing functions, as well as participating in Analytical Method Transfers.
- Compliance: Ensure strict compliance with Standard Operating Procedures, registered specifications, cGLP, and cGMP regulations within the QC laboratories.
- Investigations: Ensure timely completion of Laboratory Investigation Reports (LIRs) and deviations through established Non-Conformance procedures.
- Audits & Inspections: Participate in regulatory agency inspections as required.
- Efficiency & Strategy: Plan and implement procedures and systems to maximize operating efficiency while managing and contributing to the achievement of department productivity and quality goals.
- Safety: Ensure the laboratory is operated in a safe manner at all times.
Candidate Qualifications & "Must-Haves"
- Cell-Based Potency Bioassays: Minimum required hands-on experience.
- Cell Culture: Direct experience maintaining cells for the execution of bioassays.
- Compliance Background: Strong, demonstrable experience working within a GMP/GDP regulated environment.
- Immunoassay Experience: Proven experience with ELISA.
