AbbVie

AbbVie

QA Specialist (Batch Record Reviewer)

Waltham, MA, United States

Sponsorship not specifiedDetected 6 hours ago
ComplianceExcelSAPGMPMedical DevicesMicrosoft Office

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odds of building a lasting career here

38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 38 green-card filings in this occupation, 97% were for a worker who already held the job.

Green-card follow-through: 59%

Of 22 labor certifications old enough to have been used, 9 expired without the employer filing the next step. Median time from filing to decision: 480 days.97% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

DOL often reclassifies their job titles

The Department of Labor assigned a different occupation than this employer requested on 44% of its 55 wage determinations — against a 18% norm. The occupation sets the prevailing wage floor.Reclassification is routine and can reflect genuinely hybrid roles; it is not by itself evidence of underpayment.

Files H-1B transfers

7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • This QA Specialist is responsible for reviewing and release of semi-finished, and finished drug product.
  • It also involves ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices.
  • Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.

Responsibilities

  • Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.

Requirements

  • Bachelor's Degree in the Sciences or technical field or equivalent experience.
  • 5 years of experience in a quality role or experience handling and reviewing documentation records.
  • 3 years of experience in a GMP Environment.
  • Prefer experience in an aseptic manufacturing environment.
  • Quarantine and monitor product on hold and preparing required batch disposition documentation for international sites as required.
  • Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
  • Ability to exercise independent judgement and critical thinking.

Nice to have

  • SAP experience preferred.
  • Working knowledge of Quality Assurance systems, cGMP's, ISO 13485, CMDRs, and EMEA regulations preferred.

Benefits

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • 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.

Company info

  • 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.
  • 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.

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
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This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.