Manufacturing QA Compliance Analyst

AbbVie

Westport, Co Mayo
€40,500-78,500 per year
Contract
Full-time

15 days ago
Apply easily

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .Job DescriptionMore than a job. It's a chance to make a real difference.We are now recruiting a Manufacturing QA Compliance Analyst to join our diverse Aseptic Quality team in Westport, Co. Mayo, on a fixed term contract.This is a shift based role, requiring the successful candidate to work 12 hour rotational shift to support our 24/7 manufacturing areas.As the newest member of the Aseptic team, as a Manufacturing QA Compliance Analyst, you will provide real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing, partnering with Site colleagues to create an environment of the highest performance standards of Aseptic operations and driving continuous improvement in Aseptic Operations on site.So let’s tell you a little more about this role…Your key responsibilities will include;

Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing).
Ensures Aseptic operations are carried out as per Site Procedures.
Continuously observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drives a culture of Speak-Up.
Drives all aspects of Aseptic Performance of the shift team through observation and feedback.
Drives all aspects of Aseptic performance during sampling and testing.
Partners with Aseptic Mentors and Shift Supervisors to drive performance of the shift team.
Completes real-time review of Batch Record documentation.
Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms.
Provides Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions.
Participates and provides leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures.
Provides input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing.
Drives a high-performance Aseptic culture across the site.
Actively leads and supports investigations.
Reviews and Audits Batch Records real-time
Reviews and Audits Manufacturing and Testing logs as required.
Completion of Line Clearance activities
Participate in routine leadership GEMBAs of Manufacturing and Laboratory areas.
Provides key input to the development and maintenance of the Site Contamination Control Strategy.
Provides key input to the assessment of EM data and trends.

QualificationsSo, what do you need to do this role?

Third Level Degree in a Science, Quality or Engineering discipline.
5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing ideally
Strong knowledge of Regulatory Requirements
Excellent communication skills

So, does this all sound like the right role for you? Then come join Abbvie!AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.Additional InformationAbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

AbbVie