Job Description

MUST haves: Authorization to work in Ireland without sponsorship, Cell based potency bioassays min
experience, Cell culture, GMP/GDP Elisa

This job specification outlines
the general responsibilities associated with the role of QC BioAnalytical
Sciences – Senior Associate on the Manufacturing site. This role will be
responsible for leading, coordinating, facilitating, and undertaking activities
pertaining to lab operations and compliance, with minimal supervision, acting
as a role model for other lab colleagues. The role undertakes implementing
continuous improvement projects and supporting a lean culture and Right First
Time (RFT). The role also represents the QC unit by liaising with internal and
external customers.

Additionally, the role may
involve carrying out additional work functions that are not described in this
specification but are associated with their role.

 

Key Responsibilities

         Experience in a wide variety of analytical
techniques including but not limited to cell based- Bioassays, Immunoassays,
Cell Culture (use of cells to execute bioassays) and Aseptic Technique.
Experience with liquid-handling robots is also preferable.

         Plan and perform multiple, complex routine/
non-routine methods and procedures and a large variety of assays.

         Participate in the peer review of analytical
data.

         Responsible for providing technical guidance and
applying expertise and critical thinking to help to resolve technical issues.

         Lead training of staff on technical aspects of
job as required.

         Develop, revise and implement procedures that
comply with appropriate regulatory requirements.

         Qualification of analytical equipment and
related testing functions.

         Participate in Analytical Method Transfers

         Compliance with Standard Operating Procedures
and Registered specifications.

         Ensure the laboratory is operated in a safe
manner

         Maintain quality systems within the QC
laboratories to ensure ongoing compliance to cGLP and cGMP.

         Ensure timely completion of Laboratory Investigation
Reports and deviations through the Non-Conformance procedures.

         Participate in the generation and update of
SOP’s, trend data, investigations, non-conformances, validation protocols,
reports, method validation/verifications and equipment qualifications.

         Participate in regulatory agency inspections as
required.

         Plan and implement procedures and systems to
maximise operating efficiency.

         Manage and contribute to the achievements of
department productivity and quality goals.


Requirements

Qualification / Experience:

         Bachelor’s degree in a Science related field is
required.

         4+ years of biopharmaceutical QC experience or
related quality control or GMP laboratory experience in the pharmaceutical or
medical device industry,

         Cell based potency bioassays min experience,
Cell culture, GMP/GDP Elisa

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