Specialist, Production Project Support

Orca Bio•Sacramento, CA

6d•Onsite

About The Position

The Specialist, Production Project Support supports the execution and documentation of business process improvements, change controls, CAPA initiatives, and the development and maintenance of Standard Operating Procedures (SOPs). This role works cross-functionally with production, quality assurance, engineering, and continuous improvement teams to ensure timely and compliant execution of changes and improvement projects within a regulated manufacturing environment.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or related field.
2+ years of experience in a GMP-regulated biotech or pharmaceutical environment.
Strong understanding of cell therapy, biotech or pharmaceutical manufacturing processes
Proven track record of successfully implementing improvement projects
Excellent communication, leadership, and organizational skills.

Nice To Haves

Project management knowledge is a plus.
Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred.
PMP Certification or equivalent formal project management training is preferred
Familiarity with Lean Six Sigma or operational excellence methodologies is a plus

Responsibilities

Assist in the identification, documentation, and implementation of business process improvements to enhance efficiency, quality, and cost-effectiveness.
Coordinate data collection and analysis to support root cause investigations and improvement initiatives.
Support the preparation, tracking, and execution of change control documentation in compliance with quality and regulatory standards.
Ensure all impacted stakeholders are involved in the review and approval of changes.
Maintain accurate records of change implementation and outcomes.
Support the execution and documentation of corrective and preventive actions, including follow-up activities.
Assist in CAPA investigations by compiling data, organizing cross-functional meetings, and tracking completion of action items.
Ensure CAPA documentation meets internal and regulatory expectations.
Draft, revise, and maintain SOPs in collaboration with subject matter experts.
Ensure SOPs reflect current best practices and regulatory requirements.
Facilitate training rollout and ensure personnel are informed of updated procedures.
Track progress of ongoing production-related projects and report on milestones, issues, and risks.
Schedule and facilitate cross-functional meetings as needed to support project deliverables.
Maintain accurate and organized project documentation.