Quality Assurance Specialist

1 week ago

Fort Washington, Pennsylvania, United States Mindlance Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Mindlance. The successful candidate will be responsible for providing daily Quality Assurance support to our manufacturing site, ensuring compliance with internal and regulatory cGMP and CFR requirements.

Key Responsibilities
  • Provide daily 'Shop Floor QA support to warehouse, bulk manufacturing, and packaging lines.
  • Lead QA Shop Floor activities, including communication of quality events to management.
  • Perform or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
  • Support Investigations and/or Investigation Protocols, including conducting, writing, reviewing, and approvals.
  • Participate in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's).
  • Provide support to Consumer Complaint investigations.
  • Actively support Site metrics, compliance improvement, and training initiatives.
Requirements
  • 3-5 years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement.
  • Technical B.S. or B.A. College Degree in Science is preferred.
  • Active cGMP Interpretation and Application Experience.
  • Demonstrated leadership- possesses the ability to lead a team.
  • Strong Organizational Skills.
  • Strong Communication/Interpersonal and Facilitation Skills (verbal, written, and presentation).
  • Problem Solving/Investigation Experience.
  • Expertise in Handling Multiple Priorities.
  • Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance.
  • Investigation Documentation.
  • Experience with Liquid Dose processing and packaging technology preferred.
  • Validation Experience preferred.
What We Offer

Mindlance offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to providing our employees with the tools and resources they need to succeed.

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