Senior QA Manufacturing Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
AbbVie Biologics Ballytivnan seeks a Senior Manufacturing Compliance Specialist to strengthen our Quality Assurance this role youll help ensure product excellence through quality compliance incident resolution and floor-level support within a collaborative manufacturing environment.
Responsibilities
- Ensure all products and process simulations meet standards for market/investigational use.
- Provide quality guidance and compliance oversight throughout manufacturing.
- Lead or support investigations related to non-compliance in product or processes.
- Mentor train and provide support to shift team members.
- Audit batch documentation review logs and process SOPs.
- Support and execute line clearance raw material checks and stability program activities.
- Manage and maintain finished product status labeling and quality logs.
- Conduct daily manufacturing area walkarounds and seek process improvements.
- Support quality aspects of MVI AQL and NPI process/material handovers.
- Maintain compliance with cGMP HPRA/FDA EHS and AbbVie standards.
Qualifications :
- Third-level degree in science quality or engineering.
- Minimum 3 years experience in a GMP quality/operations setting (biologics preferred).
- Strong experience in aseptic processing and advanced knowledge of regulatory requirements.
- Excellent written/verbal communication and interpersonal skills.
- Experience as a trainer preferred.
- Demonstrated commitment to quality problem-solving and continuous improvement.
Additional Information :
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
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About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
