Senior Quality Assurance Associate

3 weeks ago


Marquand, Missouri, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Associate to join our team at BioSpace, Inc. The ideal candidate will have a strong background in quality assurance and a passion for ensuring the highest standards of quality in our products.

Key Responsibilities
  • Provide quality support for Active Pharmaceutical Ingredient (API) batches, ensuring they meet specifications and are manufactured in accordance with validated processes.
  • Ensure compliance with cGMP requirements and regulatory commitments.
  • Evaluate and disposition API batches and manufactured penultimate batches.
  • Provide feedback, coaching, and mentoring to QA personnel on the interpretation of Global Quality Standards and cGMPs/regulatory regulations.
  • Holistically review the impact of deviation investigations and change control on batch release.
  • Maintain awareness of internal audit findings and external regulatory agency inspections.
  • Participate in the eAPR process and approve internal release limits for APIs.
  • Support internal audits and regulatory inspections.
  • Review and approve documentation supporting manufacturing, including deviations, changes, procedures, protocols, and training documents.
  • Act as a liaison for US and OUS customers to resolve concerns.
  • Assist in establishing and revising Quality Agreements with affiliates and customers.
Requirements
  • GMP manufacturing knowledge and/or experience.
  • BS in a science-related field, such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
Preferred Qualifications
  • Thorough technical understanding of quality systems and regulatory requirements.
  • Demonstrated coaching and mentoring skills.
  • Experience in root cause analysis.
  • Demonstrated application of statistical skills.
  • Experience in API or finished product manufacturing, QA, or Engineering.
  • Experience with system and equipment qualifications.
  • Knowledge of cGMPs and quality systems.
  • Demonstrated strong written and verbal communication skills.
  • Strong attention to detail.
  • Excellent interpersonal skills and networking skills.
  • Ability to organize and prioritize multiple tasks.
  • Demonstrated flexibility when faced with changing priorities.
  • Proficiency with computer system applications and process automation systems.
Additional Information
  • Must complete a learning plan for the Senior Quality Assurance Associate role.
  • No certifications are required.
  • Tasks require entering manufacturing and laboratory areas, which require wearing appropriate PPE.
  • Must carry a cell phone to support 24-hour/day operations.
About BioSpace, Inc.

BioSpace, Inc. is a global healthcare leader dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities when vying for positions. We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups offer strong support networks for their members and help our company develop talented individuals for future leadership roles.

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