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Quality Specialist - II (Associate)
Talent Technical Services, Inc
- 🇺🇸 United States
- On-site
- 1 day ago
- $45.00 – $45.86 / hour
- GMP
- Technical Writing
- Microsoft PowerPoint
- Excel
- Microsoft Word
- SAP
1 day ago
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)
BVDQ Contractor Job Description – Large Molecule QA
The Large Molecule QA Contractor will support biologics and vaccine development operations by applying GMP knowledge, global regulatory expectations, and quality systems experience.
Responsibilities include SOP authorship/revision, training curriculum organization, documentation review, and cross-functional quality support.
Key Responsibilities
Support large molecule development and manufacturing activities in alignment with GMPs, quality standards, and global regulatory expectations.
Author, review, and revise SOPs, work instructions, and controlled documents.
Maintain training curricula to ensure role-based requirements are current and complete.
Identify compliance risks, documentation gaps, and improvement opportunities.
Support inspection readiness through organized, accurate, and retrievable documentation.
Quality Specialist - II (Associate) · Talent Technical Services, Inc