Quality
Specialist Quality Assurance
The Quality Assurance (QA) Specialist will be an active member of the ADL QA team. The QA Specialist will be assigned to the Incoming Quality Assurance (IQA) functional area, which is responsible for the inspection and release of incoming primary and secondary packaging components and sampling of raw materials. The QA Specialist will report to a QA Senior Manager.
In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Incoming Quality Assurance Specialist Key Responsibilities
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience, and knowledge.
Basic Qualifications:
University degree - Engineering or Science related discipline preferred.
Relevant experience (8+ years) 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:
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven abilities in decision making and influencing
Strong organizational skills, including ability to follow assignments through to completion
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
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