Quality Assurance Specialist
5 days ago
Quality Assurance Specialist
About the Role
We are seeking a highly skilled Quality Assurance Specialist to join our team at Curia. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products and processes.
Key Responsibilities
- Provide QA oversight and subject matter expertise for current Good Manufacturing Process (cGMP) investigations.
- Work with Quality and Operations to ensure facilities and processes are in a constant state of readiness for regulatory and customer inspections.
- Support product complaints, deviations, and failure investigations.
- Contribute to CURIA's core values of Curiosity, Urgency, Respect, Integrity, and Accountability.
- Review and close investigations and customer concerns.
- Perform root cause analysis and implementation of corrective action for process-related concerns.
- Recommend and initiate changes to applicable SOPs.
- Support CURIA Compliance department during FDA and other agency inspections as well as customer and internal audits.
- Maintain a working knowledge of government and industry quality assurance codes and standards.
- Participate in site or global projects and improvement efforts, as needed.
Requirements
- Bachelor's Degree in Science, Chemistry, Biology, or related field of study, preferred.
- Associate's Degree in Science, Chemistry, Biology, or related field of study.
- Minimum of three (3) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.
- Must know the US, European, and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory.
What We Offer
- Generous benefit options.
- Paid training, vacation, and holidays.
- Career advancement opportunities.
- Education reimbursement.
- 401k program.
- Learning platform.
Curia is an Equal Opportunity Employer
We are committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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