QA Specialist (Batch Record Reviewer)

Biopharma Careers; Waltham (MA); Sur place; USD 85 000 - 125 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical/dental/vision insurance

401(k) plan

Résumé du poste

AbbVie is seeking a QA Specialist in the United States to review and release semi-finished and finished drug products, ensuring adherence to cGMP and SOPs. You will quarantine and monitor on-hold products, and prepare batch disposition documentation for international markets.

The role requires a sciences degree, 5 years of quality experience, GMP exposure, and familiarity with SAP/Maximo/Trackwise. AbbVie offers a comprehensive benefits package and room for career growth.

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.
• 3 years of experience in a GMP environment.
• SAP experience preferred; familiarity with ISO 13485, CMDRs, and EMEA regulations preferred.

Responsabilités

• Perform QA review and release of semi-finished and finished products.
• Review batch records to support release schedules and regulatory compliance.
• Quarantine and monitor products on hold prior to disposition.
• Prepare batch disposition documentation for international markets.
• Identify and resolve batch record discrepancies to prevent regulatory impact.
• Assist in maintaining dispositioned batch records for secure storage and retrieval.
• Sign off on final product release to the market.
• Exercise independent judgement and critical thinking in batch reviews.

Connaissances

Quality experience

Documentation review

Independent judgement

Formation

Bachelor’s Degree in Sciences or technical field

Outils

SAP

Maximo

Trackwise

Description du poste

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.

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 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