Quality Compliance Specialist II

The Quality Compliance Specialist is responsible to:

• Support the execution of site quality compliance programs to ensure site adherence to AbbVie Policies and current Good manufacturing practices (cGMP) requirements per regulatory standards.
• Support site quality compliance programs for Internal Audit and External Inspection Management Regulatory Affairs Submission Product Complaints Recall Management Quality Manual/ Site Master File Management Review Quality Metrics Quality Risk Management Data Governance and Quality Plan management as assigned.

Major Responsibilities:

Internal Audits and External Inspection Management

• Support in inspection management activities to ensure site inspection readiness for regulatory inspection in Pre-Approval Inspection or GMP surveillance inspection.
• Support internal lead auditor to perform self-inspection as co-auditor
• Support Compliance Partner Program in assigned site departments to ensure compliance to the requirements of applicable regulations that pertain to pharmaceutical and biopharmaceutical Manufacturing.

Compliance Systems Management

• Support in activities for Product Complaints Recall Management Quality Manual/ Site Master File Management Review Quality Metrics Quality Risk Management Data Governance and Quality Plan management.
• Support initiatives in collaboration with site functional areas/departments to ensure inspection readiness in operations

Regulatory and Filing Submission Management

• Assist in regulatory submission activities for product filing and maintenance of HSA Manufacturing Licenses and GMP certification from relevant regulatory agencies as assigned.
• Assist in maintenance of Site Master File and Quality Manual

Data Governance

• Support and assist in promotion and training Trainer for data integrity and associated procedures (e.g. Data integrity Risk Assessment Audit Trail Review) as assigned.

Quality Risk Management

• Support and assist in data collection or tracking of Quality Risk Management activities as assigned

Product Complaint and Recall Management

• Support and assist in mock recall annual exercise including planning and execution of the plan as assigned

Quality Plan

• Support and assist in data collection or tracking of Quality Plan activities as assigned.

Qualifications :

Education

• Bachelors / Masters in Sciences (i.e. Biologicals Biomedical Chemistry Life Sciences Pharmaceutical) Pharmacy or Engineering (i.e. Biomedical Chemical Pharmaceutical) or equivalent.

Essential Skills Experience and Competencies (includes Licenses Credentials)

• A minimum of 2-5 years in a cGMP regulated environment is required.
• A minimum of 2 years of relevant experience in compliance and audit is preferred.
• Specialization in quality / compliance areas such as audit management product review customer complaints management review quality metrics quality risk management and data governance in either small molecule API or Biologics manufacturing is preferred.
• Good knowledge of regulatory standards and guidelines (such as ICH CFR Eudralex PIC/S) is preferred.
• Proven problem-solving skills and the ability to adapt to changes is preferred.
• Strong communication skills both verbal and written are required.
• Strong interpersonal skills are preferred.

Additional Information :

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time