Quality Systems Associate (Contract)

ORIC Pharmaceuticals; San Diego (CA); Sur place; USD 71 635 000 - 95 991 000; Plein temps

Résumé du poste

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company based in San Diego seeking a Quality Systems Associate to support document control, training, and quality systems activities. You will collaborate with QA, Regulatory and external partners to ensure compliant documentation and timely task completion.

Ideal candidates have 0–2 years in QA or regulated settings, strong writing skills, and proficiency with Microsoft Office; familiarity with GMP guidelines and electronic quality

Qualifications

• 0–2 years in QA or regulated academic setting.
• Strong writing and editing skills.
• Proficient in Microsoft Office.
• Familiarity with GMP and regulatory guidelines preferred (21 CFR 11/210/211; ICH GMP; EU EudraLex V4).
• Experience with electronic quality systems a plus (Veeva/MasterControl).

Responsabilités

• Support document processing, review and release of regulated GxP documents.
• Collaborate with document owners to resolve discrepancies identified during review.
• Organize review and support activities to meet pre-established timelines.
• Participate in cross-functional program meetings to provide QA updates.
• Maintain and update electronic quality systems and documentation files.
• Facilitate GMP training for internal employees/departments as required.
• Identify and drive continuous improvement of internal policies, SOPs and work instructions.
• Provide document support for internal audits and regulatory inspections.
• Perform all duties in keeping with ORIC’s core values and applicable regulations.

Connaissances

Quality Assurance

GxP knowledge

Documentation

Writing

Communication

Independent work

Time management

Cross-functional

Teamwork

Outils

Microsoft Office

Veeva

MasterControl

Description du poste

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 www.oricpharma.com , and follow us on X or LinkedIn .

Reporting to the Quality Systems Specialist, the Quality Systems Associatewill support document control, training, and quality systems activities, providing word processing, archival and electronic system maintenance. The successful candidate will work closely with Quality Assurance, Technical Operations, Clinical, Regulatory and third-party Contract organizations.

Job Description

• Support document processing, review and release of regulated GxP documents .
• Collaborate closely with document owners to resolve any documentation discrepancies identified during review.
• Organize review and support activities to ensure timely review and completion of documentation task to meet pre-established timelines.
• Participate in cross functional program meetings to provide appropriate QA updates.
• Maintain and update electronic quality systems, documentation files and folders in accordance with written SOPs.
• Facilitate/coordinate GMP training for internal employees/departments as required.
• Identify and facilitate continuous improvement of internal Policies, SOPs and Work Instructions, as needed.
• Provide document support for internal audits and regulatory inspections, as needed.
• Perform all duties in keeping with ORIC’s core values, policies and all applicable regulations.

Qualifications

• 0-2 years of relevant experience in Quality Assurance or experience in an academic or regulated environment.
• Highly polished writing and editing skills.
• High degree of proficiency in Microsoft Office Suite.
• 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 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 hourly rate for candidates who will work on-site at our San Diego location is between $25.00-$33.50 per hour. The final rate 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.This position is not eligible for H-1B visa sponsorship.

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.

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