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Job Description

Specialist Quality Assurance Aseptic Compliance

The Quality Assurance Aseptic Compliance (QAAC) Specialist is a senior and active role within the broader QA function.

The QAAC Specialist will be required to be a Subject Matter Expert in aseptic compliance. QAAC specialist will be required to understand and grasp a broad range of quality related competencies with emphasis on aseptic processing, environmental monitoring/ control, and aseptic behaviours. In addition to routine Quality Assurance duties, QAAC 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 records, systems or processes related to aseptic compliance.

Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QAAC Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

General QAAC Specialist Responsibilities:

Perform all activities in compliance with Amgen safety standards and SOPs

Represent ADL QA on multi-site workstreams related to Aseptic Compliance.

Own and drive QA led improvement projects

Provide Quality direction and input at Deviation and Change Control Review Boards and assume oversight of Deviation, CAPA and Change Control records; ensuring scope of record is clear and implementation activities are robust and timely (Aseptic Related Records such as Environmental Monitoring Excursions, Aseptic Breaches or Contamination events).

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

Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.

Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. (Aseptic Related Records such as Environmental Monitoring Excursions, Aseptic Breaches or Contamination events).

Participates in customer complaint investigations.

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

Act as Quality Aseptic Compliance point of contact during batch manufacture, provide advice to ensure all activities meet internal and regulatory expectations.

Aseptic oversight during sterile formulation and filling.

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 QAAC Specialist are typically acquired through the following combination of education, experience, and knowledge.

Basic Qualifications:

University degree - Engineering or Science related discipline preferred (Microbiology disciplines an advantage).

Relevant experience (5+ 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.

Experience working in aseptic operations, protein formulation, vial and syringe filling, and Lyophilised product manufacture.

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.