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 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.
Perform all activities in compliance with Amgen safety standards and SOPs Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies, and procedures.
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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