QA Specialist (Batch Record Reviewer)

Allergan; Waltham (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

You will quarantine on-hold products, prepare batch disposition documentation for international sites, and perform final sign-off with independent judgement.

Requires a Bachelor’s in science or technical field, 5 years in quality, GMP experience, and familiarity with SAP, Maximo, and Trackwise.

Qualifications

• Bachelor’s degree in sciences/technical field or equivalent experience.
• 5 years of experience in a quality role or reviewing documentation records.
• GMP/cGMP, ISO 13485 knowledge preferred.
• SAP experience preferred; familiarity with Maximo and Trackwise.

Responsibilities

• Perform QA review and release of semi-finished and finished drug products.
• Review batch records to support release schedules and regulatory compliance.
• Quarantine and monitor on-hold products 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.
• Perform final product disposition and sign-off per SOPs; exercise independent judgement.
• Apply independent judgement and critical thinking in batch assessments.

Skills

Quality Assurance

Independent judgement

Documentation review

Education

Bachelor’s Degree in Sciences or technical field

Tools

SAP

Maximo

Trackwise

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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