2 Compliance Investigator Jobs in College Station, TX
Azzur Group is Hiring a Compliance Investigator Near College Station, TX
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
The Compliance Investigator investigates and writes exception documents for compliance to procedures and coordinates quality system programs and projects to ensure regulatory compliance. The Investigator will coordinate, develop, track and manage investigations per procedures. The investigator will also assure all exception documentation adequately address root cause, corrective and preventive actions and product impact.
Responsibilities:
- Conduct investigations into process excursions, procedural exceptions and nonconforming events.
- Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations. Synthesize recommendation for action based on procedural requirements, decision flowcharts, and critical thinking.
- Document investigations results.
- Develop, implement, manage and track effectiveness of corrective action plans for exceptions.
- Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes as required.
- Manage projects to ensure they are completed within the required time schedule as required per quality systems.
- Provide support activity during regulatory or 3rd party audits.
- Utilize trend data to develop schedule and incorporate into facility investigations.
- Ensure accurate investigation schedules are maintained and communicated to management.
- Deliver notifications to management.
- Adhere to all company guidelines, SOPs and ensure required compliance training is up to date.
- Monitor GMP and regulatory compliance activities critical in a regulatory inspection.
- Communicate GMP violations and quality systems deficiencies to management and recommend MQ product release holds until the violation is addressed.
- Must have working knowledge of Good Manufacturing Practices and regulatory requirements.
- Strong communication and organizational skills.
- Ability to communicate with all levels of management.
- Must possess strong technical writing skills to document investigation findings.
- Problem solving will be addressed in two specific ways: People and Processes.
- In the area of people, he/she must be able to foster a participative approach to problem solving. Must also be able to build an atmosphere of trust, open communication, and respect in order to handle the difficult issues in investigations and corrective action follow up.
- In the area of processes, he/she will be required to utilize technical expertise to identify and understand problems that may elevate to serious
- compliance issues.
Education and Experience:
- Bachelor's Degree is required
- Minimum of 4 years' experience in Quality, Manufacturing, Engineering, or functions or any combination of the above.
- Experience utilizing Trackwise required
- CQA or CQE preferred
- Preferred experience in one or more of the following areas: Validation principles Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical or microbiological testing principles.
- Experience in project management and quality engineering principles preferred.
Job Summary
Full Time
$71k-98k (estimate)
06/13/2024
06/28/2024
azzur.com
HATBORO, PA
200 - 500
2010
MARK O DONNELL
$50M - $200M
Business Services
Related Companies
About Azzur Group
From Discovery to Delivery, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on DemandTM facilities, to our labs, training centers, and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the worlds leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Vision: To be the premier choice of clients... and talent across our services. Mission: We will lead the healthcare and life science industries in innovative quality and compliance solutions from Discovery to Delivery. Core Values: Put others first Have courage to take action Take personal responsibility Have Fun!
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The following is the career advancement route for Compliance Investigator positions, which can be used as a reference in future career path planning. As a Compliance Investigator, it can be promoted into senior positions as a Compliance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Compliance Investigator. You can explore the career advancement for a Compliance Investigator below and select your interested title to get hiring information.
