Quality Assurance Auditor
4 weeks ago
At QPS, LLC, we are seeking a highly detail-oriented and organized Quality Assurance Auditor to join our team. As a key member of our QA team, you will be responsible for ensuring compliance with applicable regulatory guidelines and requirements.
Key Responsibilities:
- Maintain client confidentiality and ensure that any documents received for audit are controlled, protected, and secured.
- Audit QPS SOPs to ensure contents meet regulatory requirements and interpretations.
- Review equipment and laboratory records, and Employee Qualification Manuals to ensure compliance with SOPs.
- Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOPs, procedures, and actual data results obtained during the study.
- Compare analytical procedures to the protocol and validated methods to ensure proper study conduct.
- Identify noncompliance and deviations, and recommend corrective and preventative actions in an educational and persuasive manner.
- Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director, and Management, and verify their follow-up responses are adequate and complete to close the audit.
- Assist with client and government audits or any department goals as requested by supervisor or manager.
Requirements:
- Ability to understand and comply with GLP regulations, principles, and Guidance Documents.
- Ability to identify resources and use them to formulate solutions, make decisions, and implement them.
- Ability to anticipate and identify critical issues or problems and recommend solutions.
- Ability to deal with conflict and drive resolution independently or through proper chain-of-command.
- Effective verbal and written communication skills.
- Proven ability to exercise good judgment and effectively balance work activities and changing priorities.
Education/Experience:
- Bachelor's degree in Chemistry, Biochemistry, Pharmacology, or related scientific discipline preferred.
- ≥ three (3) years experience working in a regulatory environment or position (GLP, GCP, or GMP), a plus.
- Experience in mass spec chromatography and/or ELISA and familiarity with various lab equipment are preferred but not absolute requirements.
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