Hybrid QA Specialist - North Chicago, IL na AbbVie
AbbVie · North Chicago, Estados Unidos Da América · Hybrid
- Professional
- Escritório em North Chicago
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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.
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.
Job_Category
Operations
Minimum Education Required
High School/GED
Certificates/Security Clearances/Other
City*
North Chicago
Additional Qualifications/Responsibilities
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
Salary: $58,656 - $100,500
•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
Salary: $58,656 - $100,500
State*
Illinois
