Associate Quality Control

Quality Control NPI Snr Associate

Purpose Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterisation, sample and data management.

* Contributes to team by ensuring the quality of the tasks/services provided by self

* Contributes to the completion of milestones associated with specific projects or activities within team

This role will support QC, Process Development and manufacturing operations, as such some extended hours, weekend work flexibility and shift work may be necessary as required.

Responsibilities: * QC Representative for NPI activities and routine Product meetings

* Assist with activities related to QC projects and/or QC tasks within Site projects

* Plan and perform non-core testing related to NPI activities

* Manage all sample management activities related to NPI activities throughout the site

* Create/own sample plans, SOP's and documentation related to NPI

* Responsible for their own training and safety compliance.

* LIMS data coordination of non-core (NPI) activities.

Specific Job Duties: * With a high degree of technical flexibility, work across diverse areas within QC

* Plan and perform analyses with great efficiency and accuracy.

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

* Report, evaluate, back-up/archive, trend and approve analytical data.

* Troubleshoot, solve problems and communicate with stakeholders.

* Initiate and/or implement changes in controlled documents.

* May train others as necessary

* Participate in audits, initiatives and projects that may be departmental or organisational in scope.

* May conduct lab investigations as necessary.

* Evaluate lab practices for compliance on a continuous basis.

* Approve lab results

* May represent the department/organisation on various teams

* May interact with outside resources.

* Create APPX data files and randomisation memo to facilitate data analysis.

* May provide technical guidance. May contribute to regulatory filings.

* May represent the department/organisation on various meeting forums

* May interact with outside resources

Basic Qualifications & Experience:

Qualifications * Bachelor's degree in a science discipline.

* 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical

* Professional requirements: Demonstrated experience with current Good Manufacturing Practices, Data Integrity and sound analytical technologies (HPLC, rCE-SDS, Sub-Vis Particles, Protein Concentration/Protein Content)

* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Knowledge: * Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning

* Strong analytical ability and associated problem solving.

* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Problem Solving: * Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information

o Qualitative information

o Quantitative research

o Trend data

* Anticipates and prevents potential problems

Skills: * Take initiative to identify and drive improvements

* Communication skills (verbal and written) at all levels

o Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

o Presentation skills

o Escalate issues professionally and on a timely basis

* Decision making

* Teamwork and Coaching others

* Auditing documentation and operation process

Competencies: * Demonstrated ability to work independently and deliver right first-time results

a. Works under minimal direction

b. Work is guided by objectives of the department or assignment

i. Follows procedures

ii. Refers to technical standards, principles, theories, and precedents as needed

iii. Recognises and escalates problems

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* Auditing documentation and operation process

* Demonstrated ability to interact with regulatory agencies