Quality Assurance Associate

ORIC Pharmaceuticals•San Diego, CA

8d•$60,000 - $85,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Knowledge of GMP regulations and guidance documents is preferred
Experience with electronic quality management systems such as Veeva or MasterControl is a plus.

Responsibilities

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.