Specialist, Manufacturing QA

Responsibilities

• Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
• Ensure that products and aseptic process simulations manufactured at AbbVie Biologics Ballytivnan meet the requirements of the end users, regulatory authorities and of the company.
• Provide quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
• Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
• Lead / Assist in investigations arising out of product or manufacturing processes non-compliance.
• Review/Audit of completed Batch Records.
• Review of Manufacturing Logs as required.
• Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
• Completion of Line Clearance activities.
• Completion of Incoming Raw Material checks, including product status maintenance (as required).
• Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
• Finished product status maintenance, including labelling as required.
• Administration of Quality Logs, e.g. QA Hold, Sample Request.
• Lead operations floor daily walk around of manufacturing areas.
• Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is always maintained.
• Other support as deemed necessary.

Requirements

• A third level qualification in a science, quality or engineering discipline
• Minimum 3 years' Experience in a similar role in a Pharmaceutical or Sterile Manufacturing environment (Biologics desirable)
• A strong knowledge of regulatory requirements is required.
• Excellent written and verbal communication skills with a strong attention to detail
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Additional Information

In AbbVie Ballytivnan, we are recruiting for a QA Manufacturing Compliance Specialist to join our team. This position will report into the Quality Operations Lead and support the Quality Assurance team. The QA Manufacturing Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements. The QA Manufacturing Compliance Specialist will have responsibility to assess and report on the effectiveness of the quality system to senior management. This role requires shift work.

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