Quality Lab Analyst

AbbVie; Cincinnati (OH); On-site; USD 64,000 - 122,000; Full time

Job summary

An established industry player is seeking a Quality Lab Analyst to ensure compliance and quality assurance in QC Lab Operations. This role involves planning and implementing initiatives that support GMP compliance, coordinating lab equipment procurement, and leading investigations. The ideal candidate will have a strong background in quality assurance, excellent communication skills, and the ability to work collaboratively across teams. This position offers an exciting opportunity to make a significant impact on quality systems within a dynamic environment dedicated to innovation and excellence.

Benefits

Paid Time Off

Medical/Dental/Vision Insurance

401(k) Plan

Short-term Incentive Programs

Qualifications

• 4+ years of experience in quality assurance and oversight.
• Knowledge of QA systems and GMP compliance requirements.

Responsibilities

• Serve as compliance specialist for the QC lab.
• Coordinate lab review of compendial changes.
• Lead project teams in quality documentation.

Skills

Quality Assurance

GMP Compliance

Communication Skills

Interpersonal Skills

Negotiation Skills

Education

Bachelor’s degree in Chemistry

Bachelor’s degree in Biology

Bachelor’s degree in Pharmacy

Bachelor’s degree in Microbiology

Bachelor’s degree in Engineering

Tools

Lab Instrumentation

Job description

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Quality Lab Analyst is responsible for planning, coordinating, and/or implementing initiatives that provide quality assurance support for QC Lab Operations. Specific areas of support may include: GMP/Compliance; Change Management, Lab Equipment/Instrument procurement, installation, calibration, validation/qualification, Training and QC Lab support activities (like Testing, Stability Program and Data review). This position will help to ensure that the QC Labs operate in compliance with corporate and governmental regulations.

Responsibilities:

· Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed.

· Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed.

· Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures.

· Perform review and assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement improvements within the quality system.

· Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests.

· Participate on validation review board as area validation for equipment qualifications.

· Assist in the design of effective quality systems, procedures, and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.

· May be asked to assist in development, revision, or implementation (including delivering training) of training modules, videos, and documents to the local and to global labs.

· Support QC Stability Program (Create protocols, Sample Placement and Pull)

· Lead lab investigations and CAPA

Qualifications

•Bachelor’s degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific areas preferred.

•4+ years’ experience in quality assurance, quality oversight or relevant experience.

•Knowledge and familiarity with product testing, test method requirements, and capabilities of common lab instrumentation is preferred.

•Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.

•Experience leading teams delivering tactical results.

•Strong oral and written communication skills.

•Good interpersonal skills.

•Good negotiation skills.

Additional Information

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.

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

Compensation:
$64,000-$122,000 per year