Integrated Quality Assurance Inspector - 2nd Shift

Kindeva Drug Delivery; Missouri; On-site; USD 45,000 - 75,000; Full time

Job summary

An established industry player is seeking an Integrated Quality Assurance Inspector to ensure product quality and compliance. In this pivotal role, you will oversee equipment and material preparation, conduct batch record reviews, and collaborate with cross-functional teams to drive continuous improvement. Your expertise in cGMP regulations and quality assurance will be crucial as you proactively identify non-conformances and support incident investigations. This is an exciting opportunity to contribute to a mission that prioritizes patient health and well-being while working in a dynamic team environment.

Qualifications

• 2+ years of experience in the pharmaceutical industry.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S).
• Certified Quality Auditor (CQA) Certification preferred.

Responsibilities

• Oversee quality of equipment and material preparation.
• Coordinate support activities and review manufacturing documentation.
• Participate in internal GMP audits and support customer audits.

Skills

Quality Assurance

cGMP Knowledge

Batch Record Review

Team Collaboration

Incident Investigation

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Bachelor's degree in Microbiology

Bachelor's degree in Pharmacy

Bachelor's degree in Engineering

Job description

Integrated Quality Assurance Inspector - 2nd Shift

Join to apply for the Integrated Quality Assurance Inspector - 2nd Shift role at Kindeva Drug Delivery

Integrated Quality Assurance Inspector - 2nd Shift

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Join to apply for the Integrated Quality Assurance Inspector - 2nd Shift role at Kindeva Drug Delivery

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.
  
  

California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer

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.

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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