Senior QA Associate

Based on the nature of this role candidates will need to have an eye test as part of the selection process, this will be coordinated the same time of any interview

The Incoming Quality Assurance (IQA) Snr Associate will report to a QA Senior Manager and is a core member of the site Quality Assurance team.

The IQA Snr Associate will be responsible for sampling and testing of incoming raw materials/excipients and components.

The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.


Key Responsibilities:

* Perform Sampling of Incoming Raw Materials and Components in accordance with site procedure and ANSI standards
* Clean room raw material Sampling required in accordance with procedural requirements
* Proficiency in ANSI sampling of excipients, chemicals, primary and secondary packaging.
* Inspect Raw Materials and Components in accordance with site procedures
* Send Samples for Test to QC or Contract Laboratories in accordance with material Specifications
* Compile, Review/approve incoming batch related documentation and associated documentation in preparation for disposition activities.
* Perform all activities in compliance with company safety standards and SOPs
* Write, review and approve Standard Operating Procedures in accordance company Policies.
* Provide Quality support for triage and investigation of non-conformances (NC's)
* Responsible for drafting NC's and CAPA's
* Participates in customer complaint investigations as required.
* Provides training and advice to staff in order for them to perform their desired functions.
* Maintain the site reserve/retain samples program
* Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
* Support continuous improvement and Operational Excellence initiatives
* Any other tasks/projects assigned as per manager's request.



Basic Qualifications & Experience:

* University degree. Engineering or Science related discipline preferred.
* Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.


Preferred Qualifications & Experience:
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Strong organizational skills, including ability to follow assignments through to completion
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
* Operational Excellence experience