Specialist Quality Assurance
The Quality Assurance (QA) Specialist will be an active member of the ADL QA team.
Main Responsibilities:
* Act as Quality point of contact for incoming inspection and sampling processes, providing advice to ensure all activities meet internal and regulatory expectations.
* Oversight of ADL and external Warehouse activities.
* Manage the introduction of new techniques and equipment to IQA, including method transfers, and validations.
* Assume ownership and/or oversight of change control and Deviation/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
* Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
* Participate in product complaint investigations, as required.
* Provide training and advice to staff in relation to testing of components.
* Actively participate in audits and their preparation.
* Evaluate practices for compliance and operational excellence improvement on a continuous basis.
Requirements:
* 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.
* 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.