glp auditor.

　　pennington , new jersey

　　posted january 17, 2024

　　job details

　　summary

　　$75 - $95 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47238

　　job details

　　job summary:

　　The GLP Auditor is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Laboratory Practice (GLP), compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

　　The incumbent is responsible for QA oversight and support of an in-house GLP bioanalytical laboratory, and outsourced bioanalytical and toxicology studies.

　　The GLP Auditor supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

　　location: Pennington, New Jersey

　　job type: Contract

　　salary: $75 - 95 per hour

　　work hours: 9 to 5

　　education: Bachelors

　　responsibilities:

　　Partners with PreClinical Development Drug Metabolism and Pharmacokinetics (DMPK) and Toxicology departments to ensure GLP compliance. Reviews and approves study-related documents and plans including method development, method validation, and study data.

　　Performs internal and external audits as assigned to assure compliance with GxP regulations and guidelines including in-phase study, internal processes, data, regulatory filings, and vendors)

　　Communicates audit results to internal stakeholders and writes audit report.

　　Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs).

　　Participates in regulatory authority inspections and assists with GxP inspection readiness activities.

　　May manage, coach, and mentor junior staff.

　　Performs other tasks and assignments as needed and specified by management.

　　qualifications:

　　Bachelor's degree in a scientific discipline and a minimum of 6 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.

　　Detailed knowledge and understanding of GLP and OECD regulations.

　　Demonstrated experience leading and/or conducting QA audits.

　　Demonstrated experience developing and executing risk-based audit plans.

　　Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.

　　Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.

　　Ability to influence without direct authority.

　　Experience supporting regulatory agency inspections.

　　Proficiency with Microsoft Office.

　　Excellent verbal and written communication and skills.

　　Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

　　Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

　　Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.

　　Preferred.

　　Experience writing and reviewing SOPs

　　Bioanalytical lab experience.

　　Registered GxP Quality Assurance Certifications.

　　Experience supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections.

　　Knowledge and experience in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and/or Good Pharmacovigilance Practice (GVP) regulations.

　　skills: Quality Assurance, GLP (Good Laboratory Practice)

　　Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

　　At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

　　Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

　　Applications accepted on ongoing basis until filled.