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Quality Assurance Specialist

Columbus, OH 43228

Posted: 09/26/2023 Employment Type: Contract Job Category: Business Analyst Job Number: 586315 Is job remote?: No Country: United States

Job Description


Target PR Range: 
*Depending on experience
Duties:

  • Duties

     
    • Collaborates with OPUs, 3PQM and CMOs as needed to review and/or recommend sustainable Corrective Action/Preventive Actions (CAPAs) to be implemented at impacted sites.
    • Supports international Quality initiatives/projects.
    • Responsible for complaint trending evaluation, leads functional team meetings to ensure that Critical Events are known to local Quality management.
    • Helps collaborate and run meetings to provide data for trending of quality systems
    • Provides Quality system data to and participates in monthly cross functional Quality Management Review (QMR) meeting and monthly 3PQM QMR
    • Actively participates in alignment calls with Ridgefield, HPSG, to drive continuous process improvements.
    • Acts as local contact partner/liaison for Brand Safety & Security initiatives.
    • Makes determination when to escalate to Quality Commercial Quality and local Quality management.
    • Quality Documentation management
    • Quality Change management
    • Help to ensure Quality  procedural updates for GBS and other projects are completed and accurate
    • Help to ensure process improvements are implemented
Skills:

  • Skills
    • Ability to respond and act appropriately with all levels under time pressure and regulatory scrutiny.  For example, ability to evaluate quality issues and make strategic decisions to minimize the quality and business impact of product batches and campaigns.  Escalates and collaborates with quality management to resolve trends impacting product quality.
    • Demonstrated knowledge of FDA, cGMP, EU regulations, and USP.  Emphasis on management of current good manufacturing practices programs.
    • Demonstrated effectively applying cGMP and quality system regulations within the pharmaceutical industry. 
    • Demonstrated knowledge of Quality Assurance, Production, Laboratories or Regulatory functions within a pharmaceutical environment.
    • Excellent communication skills with the ability to influence/persuade individuals. 
    • Ability to utilize active listening skills to understand the concerns or reasoning to be responsive, gain trust, and build strategic relationships.
    • Project management expertise to arrive at quality effective and efficient processes that contribute to product quality.
    • Experience using Microsoft applications (Word, Excel) and ERP is preferred.
    • Demonstrated investigative techniques to uncover problem areas and recommend corrective actions.  
    • Problem solving ability requiring attention to detail, accuracy, cGMP, and scientific judgment.
Education:

  • Education

     
    • BA in Chemistry, Pharmacy, or related science Diploma with additional years of experience.
    • Minimum five (5) years’ experience with BS/BA pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
    • Diploma and seven (7) years’ experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Columbus, OH

Ready to embark on an exciting career journey in the vibrant Columbus, Ohio area? Known for its thriving job market, outstanding quality of life, and abundance of opportunities for professional growth, this city beckons with its infectious energy and welcoming community. Home to the renowned Columbus Museum of Art, the historic Ohio Theatre, and the beloved Columbus Blue Jackets hockey team, this region seamlessly combines art, culture, and sports to create a dynamic environment that caters to diverse interests. With delectable cuisine, picturesque parks like the beautiful Franklin Park Conservatory and Botanical Gardens, and a bustling downtown scene, Columbus is a destination brimming with charm. Take the first step towards your dream job today by exploring our job listings in this lively and enchanting locale.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.