Quality Specialist

Required Qualifications

• Bachelor's degree in science, engineering, or related discipline; advanced degree preferred.
• Minimum 5 years of experience in biologics/large molecule operations
• Experience in QA, Manufacturing, Technical Operations, or GMP documentation within biologics, vaccines, or large molecule operations.
• Working knowledge of GMPs and global regulatory expectations.
• Experience authoring, reviewing, or revising SOPs, controlled documents, or training materials.
• Strong attention to detail, technical writing, and organizational skills.
• Ability to work independently and collaborate in a matrixed environment.

Preferred Skills and Experience

• Experience with biologics, vaccines, sterile manufacturing, or clinical supply.
• Familiarity with deviations, CAPAs, change controls, batch disposition, and inspection readiness.
• Experience with document, learning, or quality management systems.
• Ability to translate requirements into clear, compliant documentation.
• Ability to manage multiple priorities in a dynamic environment.

Key Competencies

• Quality and compliance mindset
• Technical writing
• Collaboration
• Risk-based problem solving
• Attention to detail
• Adaptability in a GMP environment

Software Skills

• Microsoft PowerPoint (strong proficiency preferred)
• Microsoft Excel
• Microsoft Word
• Microsoft Office Suite
• SAP (preferred )
• Ability to appropriately leverage AI tools for training content development

Industry Experience Preferred

• Pharmaceutical industry
• Biotechnology industry
• Large Molecule/Biologics manufacturing and development
• Clinical Supply environment (nice-to-have)
• Quality oversight within manufacturing or development operations

Soft Skills

• Strong analytical and critical-thinking skills
• Excellent written communication
• Attention to detail
• Ability to organize large volumes of documentation
• Stakeholder collaboration
• Ability to work with SMEs and translate complex information into clear procedures and training materials
• Self-starter with strong time-management skills.

Notes:

• Open to Hybrid or remote.
• EST shifts(Monday-Friday)

Equal Opportunity Employer / Disabled / Protected Veterans

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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.

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:


Broughton


Branch Phone:


View phone number on click.appcast.io


Location:


Ontario, CA