QA Specialist (Batch Record Reviewer)

Posted 6 Days Ago
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Waltham, MA, USA
Hybrid
59K-104K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Reviews and releases semi-finished and finished drug products while ensuring compliance with GMP, SOPs, and regulatory requirements. Reviews batch records, resolves discrepancies, monitors quarantined products, prepares disposition documentation, and performs final product disposition in SAP. The role conducts quality checks across manufacturing, production, validation, and quality assurance documents and provides final product release sign-off using independent judgment.
Summary Generated by Built In
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

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. Quarantine and monitor product on  hold and preparing required batch disposition documentation for international sites as required.
•Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
•Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
•Quarantine and monitor product in “on hold” status prior to disposition.
•Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
•Identify and resolve all batch record discrepancies to prevent a regulatory impact.
•Assist department supervisors in maintaining dispositioned batch records to provide an efficient and secure storage and retrieval process.
•Perform all Final Product and disposition. Following global and SOPs for release in SAP. Exercise independent judgement in every batch based on evidence provided. i.e. CAPAs and their effectiveness
•Performing the Quality Assurance check of all batch related documents for manufacturing, production, validation, and quality assurance departments. Responsible for the final sign-off of the product being release to the market.
•Ability to exercise independent judgement and critical thinking.

Qualifications

•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.
•Intermediate Microsoft Word and Microsoft Excel skills. SAP experience preferred.
•3 years of experience in a GMP Environment.
•Prefer experience in an aseptic manufacturing environment.
•Working knowledge of Quality Assurance systems, cGMP’s, ISO 13485, CMDRs, and EMEA regulations preferred.
•Competency utilizing Electronic Systems ie. .Maximo and Trackwise. for Quality checks

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

Skills Required

  • Bachelor's degree in a science or technical field, or equivalent experience
  • Five years of experience in a quality role or handling and reviewing documentation records
  • Intermediate Microsoft Word and Microsoft Excel skills
  • Three years of experience in a GMP environment
  • SAP experience
  • Experience in an aseptic manufacturing environment
  • Working knowledge of quality assurance systems, cGMPs, ISO 13485, CMDRs, and EMEA regulations
  • Competency using electronic quality systems such as Maximo and TrackWise

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

AbbVie Insights

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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