About this opportunity
Company Description
About AbbVie
AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
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.
What you will do:
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.
Qualifications
What you will need:
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
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 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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 644 comparable Quality roles across 85 biopharma companies.
Salary context
110 of 644 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 644 comparable roles
+ 39 more countries
Seniority mix
309 of 644 peers have a known seniority level
Therapeutic area mix
0 of 644 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.