Compliance and Quality Assurance Specialist

7 days ago

Newark, Delaware, United States QPS, LLC Full time
Job Description

QPS, LLC is a leading Contract Research Organization (CRO) that provides a range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services to pharmaceutical, biotechnology, and medical device companies.

Job Summary

As a junior-level QA Auditor, you will play a critical role in ensuring compliance with applicable regulatory guidelines and requirements for our pharmaceutical clients. This position requires attention to detail, organization, multi-tasking, and effective communication with colleagues and clients.

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 and 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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