- Maintain client confidentiality and ensure that any documents received for audit are controlled, protected and secured.
- Audit QPS SOP(s) 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, SOP(s), 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
- 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.
- 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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Auditor I - Newark, United States - QPS, LLC
Description
Job Description
Job DescriptionQA_
QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services since 1995. Please visit our website ) for more information and to see all current openings.
Job Summary
Compliance with applicable regulatory guidelines and requirements is critical for our pharmaceutical clients, and our QA Auditors are key to ensuring that we meet these expectations. This junior-level role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent.
Essential Functions
Knowledge/Skills/Abilities
Education/Experience
QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.
