Job Description

Overview:
The Quality Assurance (QA) Snr Associate will
typically report to a Snr QA Manager and is a core member of the site Quality
Assurance team. The QA Snr Associate will serve as Quality point of contact for
Packaging operations, as well as support the complaints function.

The site is focused on continuous improvement of
all work processes and practices, therefore in addition to routine Quality
Assurance duties, QA Snr Associates may be asked to carry out additional work
functions to support site continuous improvement activities.

A variety of shift patterns may be required to
support packaging operations, including but not limited to day shift, 16/5
shift. Weekend work may also be required.

Key Responsibilities:
• Perform all activities in compliance with
Amgen safety standards and SOPs

• Observe and provide real-time Quality
oversight and support for Packaging unit operations.

• Participates in Customer complaint
investigations.

• Perform Packaging check audits.
• Provide Quality support for triage and
investigation of all classes of deviation events

• Review and approval of Deviations and CAPAs
for closure ensuring compliance with appropriate documentation, whilst ensuring
that CAPA actions address root cause and implementation plan dates are
achievable

• Review/approve production batch records, and
associated documentation in preparation for Qualified Person disposition
activities.

• Provides training and advice to staff in order
for them to perform their desired functions.

• Write, review and approve Standard Operating
Procedures in accordance with Amgen Policies.

• Support continuous improvement and Operational
Excellence initiatives

• Any other tasks/projects assigned as per
manager’s request.


Requirements

Basic
Qualifications & Experience:

• University degree. Engineering or Science
related discipline preferred.

• Relevant experience (4 yrs +) 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 & Experience:
• Excellent written and verbal communication
skills

• Experience working with dynamic
cross-functional teams and proven abilities in decision making

• 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

• Experience working with combination products
or devices in packaging-related or complaint-handling activities

• Knowledge of applicable Regulatory
requirements, and ability to evaluate compliance issues

• Operational Excellence experience

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