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QA Batch Release Specialist - 3rd Shift

Indianapolis, IN 46268

Posted: 11/30/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 593064 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $35-55/hr
 
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
  • Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
  • Controlled issuance of batch records in preparation for manufacturing.
  • Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
  • Assist functional areas with achieving timely and compliant final product disposition of the product.
  • Ensure Specifications in place and are within GMP compliance
  • Support metric tracking of documentation and release data to ensure continuous improvement.
  • Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
  • CAPA management as well as improving processes within QA Batch release
  • Organize and file all executed and associated GMP documentation (e.g. batch records).
  • Maintain batch documentation library (record check-in, check-out, follow-up, and distribution)
  • Other related duties as assigned.

Education & Qualification
  • Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree.
  • Experiences 5+ years of experience in a GxP Biopharmaceutical manufacturing operations 4+ years of experience in a quality assurance role
  • Cross functional collaboration
  • Functional Breadth
  • QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired
  • Proven track record and practical experience with cGMP requirements
  • Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.

Competencies
  • Continuous Learning (Dyn. Knowledge Development)
  • Digital & Technology Savvy
  • Operational Excellence
  • Being Resilient
  • Breakthrough Analysis
  • Interpersonal Savvy
  • Organizational Savvy

Technical / Function Skills & Knowledge
  • Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
  • Knowledge of IT Applications & tools
  • Quality Assurance
  • Quality Control (QC) Testing
  • Quality Standards
  • Sterility Assurance and Aseptic Manufacturing
  • Quality oriented with attention to details
  • Strong organizational and time management skills
  • Developed management and communication skills

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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Although this hasn't been an issue at The Planet Group, 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 The Planet Group.

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