New · posted Nov 10
AbbVie · Pharmaceuticals
Quality Control Analyst
- Irvine, CA
- On-site
- Full-time
- Associate & Specialist
The role
Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system.
What you need
What you'll do
- Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.
- Performs, coordinates and supports method validations and prepares final reports documenting the validation findings.
- Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing.
- Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.
- Reviews and approves all laboratory testing documentation. Responsible for the preparation of Test Failure Investigation reports.
- Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in SAP and LIMS.
- Responsible for leading others indirectly.
- Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.
- Must make sure that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOP’s are available to all laboratory personnel
- Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.
- Bachelor’s Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience.
- Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Knowledge of microbiology and regulatory requirements preferred.
- Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred
- Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.
- Experience working in a GMP regulated environment preferred. Audit experience preferred.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$66,000 – $126,000 a year
Employer providedPaid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Short-term incentive program
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CA
From the posting
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.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
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 applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 32% above the US median for Microbiology & Sterility Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $66,000 | — | $126,000 |
| All US (middle half) | $66,125 | $73,000 | $83,625 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 56 open Microbiology & Sterility Assurance roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods11
- Documentation and SOPs7
- Investigations and CAPA4
- Data and digital systems4
- Validation and qualification3
- GMP and compliance1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility Assurance work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and PracticesNamed in the posting
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
Company hiring pulse
AbbVie on Regulatory Jobs
- 72
- Open roles
- 72
- Distinct roles
- 17
- Locations
By discipline
- Clinical62 54%
- Quality28 25%
- Regulatory24 21%
By level
- Director55 48%
- Manager25 22%
- Senior & Principal19 17%
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Quality Control Analyst at AbbVie
Open until filled. $66K–$126K a year, employer provided.