Sr. Associate IQA - 16/5 Shift

Biopharma Careers; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

Biopharma Careers is seeking a Sr. Associate in Quality Assurance for the Incoming Quality Assurance area in Ireland. You will inspect and release primary packaging components, act as QA contact for incoming inspection, and support site continuous improvement initiatives.

The role requires a university degree in engineering or science and at least 4 years in pharma/biotech, with strong problem-solving and documentation skills. Irish facility work in a compliant, fast-paced environment.

Qualifications

• University degree in engineering or science.
• 4+ years pharmaceutical/biotech experience.
• Strong problem-solving and documentation skills.

Responsibilities

• Test and release primary and packaging components for aseptic products.
• Perform sampling of components under Grade C conditions.
• Review and approve testing documentation for disposition activities.
• Close minor NCs and CAPAs, address root causes and timelines.
• Support supplier audits and customer complaint investigations.
• Provide training on testing of components and packaging.
• Assist in audits and prepare related records.
• Write and review SOPs in line with Amgen policies.

Skills

Eye-test

Cross-functional teams

Communication

Education

University degree in Engineering or Science

Job description

Career Category

Quality

Job Description

The Sr. Associate in Quality Assurance (QA) will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.

The Sr. Associate in Quality Assurance will report to a QA Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.

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

Incoming Quality Assurance Sr. Associate Key Responsibilities

• Testing of primary and secondary components for use in the manufacture of aseptic products.
• Sampling of Excipients and Drug Substance under Grade C conditions.
• Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
• Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Participates in customer complaint investigations with suppliers of components.
• Provide training and advice to staff in relation to testing of components and packaging.
• Actively participate in audits and their preparation.
• Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Perform all activities in compliance with Amgen safety standards and SOPs
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

Basic Qualifications & Experience:

• Must Pass Eye-Tests required for Visual Inspection
• 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 / Non-Conformance /Deviation investigations
• Experience working in aseptic operations, protein formulation, vial and syringe filling.

Salary Range

55,284.00 EUR - 74,796.00 EUR