Specialist, Incoming QA

Science is at the heart of what we do. People are at the heart of why we do it.

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are recruiting a Incoming QA Compliance Specialist to join our site in Ballytivnan, Sligo. This position will report into the IQA Supervisor and support the Quality Assurance team.

A snapshot of your key responsibilities as a Biologics Technician would be:

Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.

Complete incoming quality assurance (IQA) release of raw materials, single use assemblies and bulk drug substance.

Ensure timely release of materials for manufacture of products in compliance with all site policies, procedures and timelines

Provide quality oversight of sampling requirements for excipients to ensure aseptic sampling requirements.

Leading / Assisting in investigations arising out of specifications results for IQA materials

Lease with approved contract laboratories for quotations, processing and release of samples.

Review/Audit of completed release records.

Authoring specifications and standard operation procedures

Acting as SME during regulatory and internal inspections

Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)

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.

Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.

Other support as deemed necessary.

3rd level qualification (level 8) in Science, Quality or Engineering

2+ years’ experience in a Quality role for incoming materials

3+ years experience in a regulated GMP environment

Strong knowledge of regulatory requirements

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.

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