Orca Bio

Specialist, IT & Manufacturing Systems Support (Off-Shift)

Sacramento, CA · Full-time

Sponsorship not specified$65k-$90kDetected 23 days ago

Customer SupportGMPLeadership

About the role

We are looking for a technically savvy, detail-oriented individual who can follow strict protocols, troubleshoot system access issues, and escalate complex problems to the appropriate system administrators.
Essential Duties & Key Responsibilities:
Provide Level 1 and Level 2 troubleshooting for critical manufacturing applications (e.g., TrakSYS, MasterControl, and enterprise systems) during graveyard and weekend shifts.

Triage, document, and escalate complex hardware or software issues to corresponding Tier 3 IT or system owners when immediate resolution is not possible.
Serve as off-shift MasterControl Administration and Document Control owner to ensure production documentation moves seamlessly through the pipeline. E.g., process MC tickets including account creation, termination and role assignments.
Support data entry and system routing tasks per established Good Manufacturing Practices (GMP) and data integrity guidelines.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
Support weekend and off-

Technical Savviness: 2+ years of experience in an IT Helpdesk, Technical Support, or Systems Support role (Level 1/2 troubleshooting).
Shift Flexibility: Ability to work non-traditional hours, specifically overnight shifts (10:00 PM - 6:00 AM / 6:00 PM - 6:00 AM) and weekends (Saturday/Sunday).
Process-Driven Mindset: Exceptional attention to detail with the ability to follow rigorous, step-by-step technical instructions for resolving technical issues and updating system configuration and eBRs.
Systems Familiarity: Experience with identity management/SSO tools and IT ticketing systems.
Prior experience with MasterControl (MX/QX modules) or MES system (e.g. TrakSYS) is a plus, but not required.
shift availability required for weekends (10:00 PM - 6:00 AM) and weekdays (6:00 PM - 6:00 AM).

Prior experience working within a regulated GMP manufacturing environment is highly preferred, but a strong understanding of compliance, data integrity, and 21 CFR Part 11 requirements is required.
GMP Awareness: Prior experience working within a regulated GMP manufacturing environment is highly preferred, but a strong understanding of compliance, data integrity, and 21 CFR Part 11 requirements is required.
MasterControl/MES Experience: Prior experience with MasterControl (MX/QX modules) or MES system (e.g. TrakSYS) is a plus, but not required.
Comprehensive training on basic MasterControl administration and eBR writing will be provided.

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law.

We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
shift activities as part of a 24/7 coverage model, with specific
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law.
Other perks include subsidized daily lunches and snacks at our on-site locations.

We are driven by a passion for science and compassion for patients.
We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity.
Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn't been paved.
We aren't afraid to ask "why not" and challenge the status quo.
We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.
Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only.
We do not accept unsolicited resumes, and we rarely outsource recruitment.
Who we are We are driven by a passion for science and compassion for patients.

equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.