Quality Systems Associate (Contract)

About the role

Reporting to the Quality Systems Specialist, the Quality Systems Associate will 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.

Responsibilities

• 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 tasks 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.

Requirements

• Bachelor’s degree or equivalent relevant experience.
• 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.

Pay

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.