Batch Record Specialist

Celcuity-posted 2 days ago
$70,000 - $100,000/Yr
Full-time • Mid Level
Remote • Minneapolis, MN
51-100 employees
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We are seeking a Batch Record Specialist who will report to the Executive Director, Quality Assurance. You will support the company’s Quality Assurance vision and objectives and help establish and oversee the implementation of systems and processes that meet or exceed quality standards and regulatory requirements. The Quality Assurance (QA) Batch Record Specialist is responsible for preparing the technical and final release of our products. The QA Batch Record Specialist performs functions necessary to ensure that all relevant manufacturing records are compiled, reviewed and completed in a compliant and efficient manner. This position requires attention to detail and must be performed in accordance with standard operating procedures and all applicable regulatory and GMP requirements.

  • Review, and verify executed batch records of APIs, drug products, primary and secondary labeling and packaging
  • Review and verify analytical data
  • Review and assess the relevant quality control results against acceptable limits.
  • Review and complete records ensuring compliance with applicable SOPs and regulatory regulations.
  • Communicate with CMOs on missing documentation and error corrections.
  • Archive of the entire batch documentation in eQMS (e.g. Veeva)
  • Responsible for reporting all variances, errors and deviations to supervisor.
  • Manage records in eQMS
  • Able to collaborate on complaint and/or nonconformance reports.
  • Write and implement standard operating procedures and work instructions for QA processes.
  • Support inspection readiness, as needed
  • Other duties as assigned
  • Bachelor’s degree in health or life sciences, or related field; or relevant experience.
  • A minimum of 3 years of experience in quality assurance, commercial pharmaceutical drug manufacturing and GMP’s in the pharmaceutical / biotech industry
  • Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, ICH).
  • Experience in supporting regulatory inspections and interacting with regulatory agencies / health authorities.
  • Adept at collaborating and communicating effectively with individuals across diverse roles, experience levels, and perspectives.
  • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
  • Attention to detail and ability to manage multiple processes and documentation requirements.
  • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
  • Ability to work in a team and independently as needed to ensure timely, accurate, and thorough completion of assignments.
  • Outstanding organizational skills with the ability to prioritize.
  • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
  • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
  • Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
  • Maintain a positive, approachable, and professional attitude.
  • Analytical education/background is preferred
  • medical
  • dental
  • vision insurance
  • 401(k) match
  • PTO
  • paid holidays
  • annual performance incentive bonus
  • new hire equity package
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