Senior Quality Assurance Manager

5 days ago


Bethlehem, Pennsylvania, United States Sharp Corporation Full time
About the Role

Sharp Corporation is seeking an experienced Senior Quality Assurance Manager to join our team. As a key member of our QA department, you will be responsible for ensuring compliance with cGMP standards and regulations.

Job Description
  • Lead the development and implementation of quality systems and processes to ensure compliance with FDA and EU regulations.
  • Oversee the review and approval of analytical lab documents, investigations, CAPAs, manufacturing, packaging, labels, and release of material.
  • Provide leadership and oversight to analytical lab teams, ensuring adherence to SOPs and WRKIs.
  • Develop and maintain KPIs for batch record review right first time and error tracking.
Requirements
  • Bachelor's degree in technical discipline (BS/BA) from a four-year college or university preferred with four to seven years related experience and/or training; or equivalent combination of education and experience.
  • 4-7 years in pharmaceutical or biotech manufacturing in a Quality or Compliance role.
  • Experience in analytical chemistry, compliance, and technical writing.
  • Demonstrated ability to work independently, handle multiple tasks simultaneously, and negotiate and meet critical timelines.
  • Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
  • Proficient with interpreting and implementing cGMPs, FDA & DEA Regulations, and CFRs.
  • Leadership skill to mentor and develop team to achieve company goals.
Estimated Salary Range: $120,000 - $160,000 per year

This estimate is based on national averages and may vary depending on location and other factors.



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