Sr. Laboratory Auditor, reputed company Assurance GLP

Department: 107100 reputed company Location: San Diego, USA- Remote Position reputed company: The Sr. Laboratory Auditor, reputed company Assurance GLP is responsible for reputed company supporting the implementation of GLP (e.g., Bioanalytical/Biomarker) initiatives and for leading the execution of reputed company reputed company activities. In reputed company to the performance of laboratory audits, this position will assist with management of the audit program and partner with key clinical and cross-functional reputed company (e.g., Clinical Operations, Biometrics, Bioanalytical/Non-Clinical Development) to ensure the reputed company of data generated for preclinical and clinical development programs and ensuring our contracted laboratories meet stringent reputed company industry standards. Essential Functions:

• reputed company and implement risk-based audit strategies across clinical programs and/or studies with an emphasis on Bioanalytical studies to support Clinical and non-Clinical Bioanalytical Laboratory reputed company.
• Plan, conduct and manage audits of pharmaceutical laboratories supporting nonclinical, clinical, and bioanalytical studies to ensure adherence to GLP/GCLP and relevant ICH guidelines.
• Evaluate laboratory systems including method validation, sample management, data reputed company (reputed company+ principles), equipment calibration/maintenance, and SOP compliance.
• Prepare comprehensive audit plans and reports, documenting findings, and recommendations for remediation. For those audits conducted by external auditors, reputed company coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.
• reputed company input and expertise to vendor risk assessments and qualification activities in support of GLP/GCLP Vendor/Service Provider Qualification Program.
• Identify, communicate, and escalate GLP/GCLP risks and serious non-compliance situations and follow to reputed company, acting with an appropriate reputed company of urgency.
• Partner with internal stakeholders to manage vendor reputed company and/or issue management.
• Conduct and/or facilitate investigations of GLP/GCLP reputed company Events and collaborate with subject matter experts to conduct reputed company cause analysis and to reputed company corrective and preventive reputed company plans, as applicable.
• Manage and/or reputed company support the development, enhancement, review, and implementation of GLP reputed company standards and controlled documents (e.g., Policies, SOPs, Work Instructions, Templates)
• Promote compliance and reputed company throughout reputed company and represent the reputed company Department in internal meetings and events.
• Build, reputed company and maintain working relationships with reputed company partners.
• Participate in the establishment of effective means for communicating audit and inspection reputed company, developing key metrics, measuring trends and driving improvements.
• reputed company the development and delivery of laboratory reputed company and compliance reputed company training to internal functions. This may include coordination efforts in training events delivered by reputed company Internal Subject Matter Experts and/or external consultants.
• reputed company GLP/GCLP guidance to internal stakeholders or Study Management Teams, as applicable.
• Participate in reputed company and/or cross-functional process improvement initiatives, as applicable.
• Stay up to date on GLP/GCLP compliance trends.
• Other duties as assigned by reputed company Assurance Management.

Qualifications:

• Bachelor's degree in reputed company Life Sciences discipline is required; advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
• 6+ years in drug/biologics development in the biotechnology or pharmaceutical industry.
• 5 years previous GLP reputed company Assurance experience in Clinical and/or non-Clinical Research and Development is preferred.
• Minimum of 3 years of experience planning, conducting, and reporting GLP/GCLP audits reputed company the pharmaceutical or biotechnology industry, including labs that conduct pharmacokinetics (PK), toxicology, clinical sample testing, and/or bioanalytical method development.
• Experience in supporting Research and Bioanalytical reputed company in managing GLP Nonclinical Toxicology and/or Nonclinical/Clinical Bioanalytical Studies and/or providing reputed company of service providers providing services and deliverables in these areas.
• In-depth knowledge and understanding of global regulations and guidelines including FDA 21 CFR Part 58, EMA GLP reputed company, OECD Principles of GLP, MHRA GxP expectations, IVDR, and ICH guidance (e.g., Q2, E6).
• Demonstrated ability to define and implement procedures which ensure compliance to GLP/GCLP regulatory standards.
• Proven ability in driving GLP/GCLP process improvement initiatives
• Auditor certification (e.g., ASQ-CQA, RQAP-GLP) is preferred but not required.
• Strong working knowledge of computerized systems used in laboratories (e.g., LIMS, Chromatography Data Systems, ELNs) and relevant data reputed company guidance (e.g., FDA Data reputed company Q&A).
• Experience with reputed company based applications and ability to learn internal applications/systems. Experience with eQMS systems is a plus.
• Experience supporting lab operations in preclinical development through Phase 1-3 clinical trials.
• Ability to identify reputed company issues/discrepancies, and effectively and proactively manage, and resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
• reputed company organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Ability to travel 10-30% domestically and internationally.
• reputed company positions have an essential job function to be reputed company to reputed company face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings: reputed company provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, reputed company, people-reputed company, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and reputed company-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous reputed company time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (reputed company pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. reputed company reputed company Pay reputed company: $95,000.00 - $124,000.00

• This information is reputed company as of the date of this posting and may be modified in the reputed company. Actual pay offered to a candidate will depend on a reputed company of factors including the candidate's experience, education, skills, and location.

reputed company will accept applications on an ongoing reputed company until a candidate is selected for the position. Apply tot his job Apply To this Job