Quality Assurance Associate

Company Description

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to and follow us on X or LinkedIn.

Reporting to the Quality Assurance Manager, the Quality Assurance Associate will support Technical Operations activities, providing review and disposition of manufacturing and testing records. The successful candidate will work closely with Quality Assurance, Technical Operations, and third-party Contract organizations.


Job Description

• Support Quality Assurance (QA) Batch Record Review, Product Disposition in the review and assessment GMP manufacturing and testing records ensuring all records are complete, accurate and compliant prior to product disposition.
• Collaborate closely with Technical Operations and/or third-party contract organizations to resolve any documentation discrepancies identified during review.
• Support GMP investigation processes by assisting in gathering information and data to the responsible investigators conducting root cause analysis, assessing product impact and identifying corrective and preventive actions in accordance with written Standard Operating Procedures (SOPs).
• Organize review and support activities to ensure timely review and disposition of materials and/or product to meet manufacturing and clinical program timelines.
• Participate in cross functional program meetings to provide appropriate QA updates.
• Maintain and update GMP controlled batch tracking tools, documentation files and folders in accordance with written SOPs.
• Facilitate GMP training for internal departments as required.
• Identify and facilitate continuous improvement of internal Policies, SOPs and Work Instructions, as needed.
• Support internal audits and regulatory inspections, as needed.
• Perform all duties in keeping with ORIC's core values, policies and all applicable regulations.

Qualifications

• Bachelor's or Master's degree in Life Sciences, or a related discipline
• 0-3 years of relevant experience in Quality Assurance or 1-2 years of relevant laboratory experience in an academic or regulated environment.
• Knowledge of GMP regulations and guidance documents is preferred, including but not limited to:
  • 21 CFR Parts 11, 210, 211
  • Applicable ICH Quality Guidelines for Good Manufacturing Practices (GMP)
  • EU EudraLex Volume 4
• Experience with electronic quality management systems such as Veeva or MasterControl is a plus.
• Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work.
• Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met.
• Excellent verbal and written communication skills

Additional Information

The anticipated salary range for candidates who will work on-site at our San Diego location is between $60,000-$85,000 for Associate level. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.

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.