Quality Assurance Specialist

Essential duties and responsibilities include the following. Other duties may be assigned.

• Assist in the implementation and maintenance of GXP/nonGXP systems and equipment that support clinical development or commercial activities ensuring compliance with applicable regulatory requirements.
• Support the evaluation creation and/or review operating procedures (eg policies SOPs etc. and other documentation to align with quality management system for a clinical and commercial stage company.
• Participate in the preparation of quality/KPI metrics to support GXP activities and management review.
• Support the compliance with Quality Agreements with crossfunctional teams CDMOs and contract laboratories as identified.
• Ensures Clinical Trial Materials are properly tested and released by reviewing batch records Certificates of Analysis (COAs) and associated data for the release of Clinical Trial Materials and GMP products.
• Coordinate identify and address quality risks support resolutions and ensure mitigation as applicable for crossfunctional teams compliance. Work with crossfunctional team to ensure support commercial readiness.
• Support the implementation maintenance and of the Inspection Readiness program and support activities related to readiness scorecard across all GXP functions in all stages of development or commercialization.
• Support the Annual Management Quality Review Program by preparing relevant data and documentation as required.
• Support key Quality Systems as required including Product Quality Review (PQR) or CAPA process.
• Perform training for crossfunctional teams on QMS processes.
• Demonstrates a high level of independent judgment.

Perform all duties in keeping with the Companys core values policies and all applicable regulations.

Qualifications :

• 5 years industry experience in a Qualityrelated position. Bachelors degree in a relevant field (or equivalent).
• Experience supporting quality systems for clinical and commercial drug products.
• Working knowledge of GXP Federal Regulations including 21 CFR Part 11 regulations and quality systems.
• Experience quality management programs in the pharmaceutical or biotechnology industry is a plus.
• Knowledge and hands on experience in supporting electronic (GXP) systems such as TrackWise Intellect or Veeva is a plus.
• Effective oral and written communication skills. Strong interpersonal skills. Ability to successfully solve challenging issues perform critical thinking and be detail oriented.

Excellent organizational ability can easily multitask and shift priorities as needed.

Additional Information :

The anticipated salary range for candidates who will work in our San Diego location is between  $110000$125000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc. 

ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.

Remote Work :

No

Employment Type :

Fulltime