QA Specialist II

AstraZeneca • Bogart, GA

7d

About The Position

Executes core processes related to internal and external quality, such as managing deviations, complaints, and supplier quality. Ensures timely data entry and documentation within specific area of quality including advising on batch disposition, reviewing and approving investigations, and conducting customer complaint investigations. Provides guidance on GxP and leads training on Good Manufacturing Practices (GMP). Coordinates regulatory documentation and supports process improvements, risk assessments, and data analysis for quality metrics and key performance indicators. Offers support for site accreditations and product reviews ensuring adherence to guidelines and regulations. Typical Accountabilities Execute core processes applicable to own area of internal / external quality (e.g. deviation management system; global complaint management system, supplier management, product quality reviews). Conduct timely data entry and documentation related to own quality area. Advise on deviations to make batch disposition recommendations to approve or reject batches. Review and approve investigations to ensure root cause is established and relevant CAPAs are in place. Conduct customer complaint investigations and approve investigation reports. Conduct ongoing reviews and approvals of documentation as applicable (i.e. changes within the change management framework; validations and qualifications; product quality reviews, periodic reports, regulatory documents, and change errands). Provide advice on GxP within the site, with reference to guidelines and regulations. Lead formal and informal training including GMP training. Coordinate referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews. Support process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices. Support data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes.

Requirements

• HS Diploma with 2+ years of Experience or Entry Level BS Degree with 0+ years of experience in Science/Engineering Field such as Pharmacy, Biology, Chemistry or related field.
• Experience working with principles and concepts of compliance management related to GxP, SOPs, & SHE requirements.
• Relevant experience in executing quality management processes within a highly regulated environment.
• Experience working with digital tools and applications related to QA reporting, documentation, and analysis.

Responsibilities

• Execute core processes applicable to own area of internal / external quality (e.g. deviation management system; global complaint management system, supplier management, product quality reviews).
• Conduct timely data entry and documentation related to own quality area.
• Advise on deviations to make batch disposition recommendations to approve or reject batches.
• Review and approve investigations to ensure root cause is established and relevant CAPAs are in place.
• Conduct customer complaint investigations and approve investigation reports.
• Conduct ongoing reviews and approvals of documentation as applicable (i.e. changes within the change management framework; validations and qualifications; product quality reviews, periodic reports, regulatory documents, and change errands).
• Provide advice on GxP within the site, with reference to guidelines and regulations.
• Lead formal and informal training including GMP training.
• Coordinate referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews.
• Support process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices.
• Support data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED