Job Title: Technical Operations & Quality Investigations Specialist
Role Overview
We are seeking a Technical Operations & Quality Investigations Specialist to provide direct technical support to our manufacturing teams. You will be at the forefront of maintaining process integrity, tasked with identifying the "why" behind production atypical events, leading root-cause investigations, and implementing corrective/preventative actions (CAPA) to drive continuous improvement.
This is a high-impact role for an early-career engineer or scientist who thrives on data-driven troubleshooting. You will work cross-functionally with manufacturing, quality, and process development teams to resolve technical challenges and ensure our production processes are robust, compliant, and efficient. If you have a passion for critical thinking and want to play a key role in operational excellence, this is your opportunity.
Key Responsibilities
Investigation & Technical Support
• Technical Troubleshooting: Provide day-to-day scientific and engineering support to manufacturing operations. Lead the investigation of atypical events, analyzing complex problems to identify systemic root causes.
• CAPA Execution: Develop and implement effective corrective and preventative actions (CAPA) to address process deviations and prevent recurrence.
• Process Integrity: Utilize sound scientific and engineering principles to ensure manufacturing processes operate within defined specifications. Drive the reduction of process deviations through proactive process monitoring.
Documentation & Collaboration
• Formal Reporting: Author technical investigation reports that are accurate, clear, and audit-ready. You will be responsible for translating complex technical findings into logical, scientific conclusions.
• Cross-Functional Partnership: Build strong working relationships with counterparts in production, testing, planning, and quality assurance. Facilitate communication between departments to ensure timely resolution of issues.
• Continuous Improvement: Apply Lean Six Sigma methodologies to analyze production data and suggest improvements to current manufacturing workflows.
Qualifications & Requirements
Minimum Qualifications
• Education: B.S. or M.S. degree in an engineering or scientific discipline (e.g., Chemical Engineering, Biology, Chemistry, or related field).
• Experience Baseline: 0-3 years of professional experience in a cGMP manufacturing environment (e.g., Production, Process Engineering, or Technical Services).
• Investigation Proficiency: Demonstrated ability to write technical investigations for atypical events or deviations.
• Problem-Solving Aptitude: Strong critical thinking skills; proven ability to apply analytical methodologies (such as Lean Six Sigma) to solve manufacturing problems.
• Communication: Exceptional written communication skills-you must be able to document technical events in a way that is clear and defensible during an audit.
Preferred Attributes
• Hands-on experience with process deviations, root cause analysis (RCA), and CAPA systems.
• A "scientific mindset": You are comfortable diving into data, identifying trends, and proposing solutions based on technical facts.
• Ability to work effectively in a fast-paced environment where priorities can shift based on manufacturing events.
Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Nichols
Branch Phone:
(909) 244-1777
Location:
Ontario, CA