Integrated Quality Assurance Inspector V

Kindeva Drug Delivery Company; Bridgeton (MO); On-site; USD 50,000 - 85,000; Full time

Job summary

In dieser spannenden Rolle bei einem führenden Unternehmen in der pharmazeutischen Industrie sind Sie für die Qualitätssicherung von Produkten verantwortlich, die Leben retten. Sie werden die Qualität von Materialien und Prozessen überwachen, sicherstellen, dass alle Produkte den regulatorischen Anforderungen entsprechen, und kontinuierliche Verbesserungsinitiativen vorantreiben. Sie arbeiten eng mit interdisziplinären Teams zusammen, um sicherzustellen, dass die höchsten Qualitätsstandards eingehalten werden. Diese Position erfordert Entscheidungsfreude und die Fähigkeit, unter Druck zu arbeiten, während Sie gleichzeitig die Integrität der Produkte gewährleisten. Wenn Sie eine Leidenschaft für Qualität und Teamarbeit haben, könnte dies die perfekte Gelegenheit für Sie sein.

Qualifications

• 2+ Jahre Erfahrung in der pharmazeutischen Industrie erforderlich.
• Kenntnis der cGMPs (USFDA, Health Canada) ist erforderlich.

Responsibilities

• Überprüfung von Dokumenten zur Gewährleistung der Einhaltung von SOPs und cGMPs.
• Proaktive Identifizierung und Behebung von Nichtkonformitäten in der Produktion.

Skills

Qualitätskontrolle

Entscheidungsfindung

Teamarbeit

Datenanalyse

Education

Bachelor-Abschluss in Chemie

Bachelor-Abschluss in Biologie

Bachelor-Abschluss in Pharmazie

Bachelor-Abschluss in Ingenieurwesen

Tools

SOPs

Batch Record Review

Job description

Integrated Quality Assurance Inspector - 2nd Shift

Bridgeton, MO, USA

Job Description

Posted Tuesday, April 1, 2025 at 4:00 AM

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

In this role, you will be responsible for overseeing the quality of equipment and material preparation, as well as aseptic compounding, filling, and inspection activities. Supporting site-wide objectives, you will coordinate support activities, review and audit semi-finished product manufacturing and testing documentation, and ensure that all released products comply with regulatory and cGMP requirements. The IQI collaborates with cross-functional teams to drive continuous improvement initiatives, support incident investigations, and implement necessary changes. This position requires strong decision-making abilities related to incident investigations and corrective and preventive actions, with a focus on overall quality, site priorities, and performance outcomes.

ROLE RESPONSIBILITIES

• Responsible for reviewing documents to ensure the manufacturing and testing processes adhered to the approved batch/testing record and are compliant with approved SOP’s and cGMPs.
• Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation review.
• Proactively identify and address non-conformances in manufacturing operations.
• Performs timely reviews and determines batch acceptability and product disposition.
• Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
• Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.
• Alert management promptly to any issues identified during batch record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
• Review and edit SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.
• Participates in internal GMP audits and supports customer and regulatory audits.
• Assists in review and editing of SOPs / Master Batch Records.

BASIC QUALIFICATIONS

• Bachelors degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline.
• 2+ years of experience in the pharmaceutical industry.
• Experience in Batch Record Review/Audit/Disposition.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Independently consistently produces quality work.
• Works in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Collects, researches, analyzes, and presents data information skillfully.
• Certified Quality Auditor (CQA) Certification preferred.

PHYSICAL QUALIFICATIONS

• Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
• Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may occasionally include weekends and holidays.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!