QA Specialist, Materials Test and Release.
12 Month Contract.
This role is a 12-month contract role in our clients QA Department, under their QA Materials Test & Release team. This specific role is required to perform activities such as QA Review & Release of Packaging Components & Starting Materials, QA review of Materials with Temperature monitoring devices associated them and QA review of materials that have expired. This position requires a good knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
Essential Duties and Job Functions:
Participates within inter-departmental and cross-functional teams
Reviews routine release documentation for Packaging Components & Starting Materials
Review of temperature monitoring devices associated with incoming product
Initiation of the Disposal of expired materials
May assist with investigations and corrective and preventive action (CAPA) relating to materials/components/batches.
Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP
Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
Exercises judgment within defined procedures and practices to determine appropriate action
Normally receives very little instruction on routine work, general instructions on new assignments
Knowledge, Experience and Skills:
Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
Demonstrates working knowledge of quality assurance systems, methods and procedures.
Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
Demonstrates audit and investigation skills, and report writing skills.
Good verbal, written, and interpersonal communication skills.
Proficiency in Microsoft Office applications.
Typical Education & Experience:
2+ years of relevant experience in a GMP environment related field and a BS.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.