Aptask Global Workforce (AGW) is seeking a Quality Specialist - II for a Onsite position with a Major Pharmaceutical Company located in West Point, PA. This is a 12 month contract opportunity. This role supports biologics and vaccine development operations by applying Good Manufacturing Practices (GMP) knowledge, global regulatory expectations, and quality systems experience. Responsibilities include SOP authorship and revision, training curriculum organization, documentation review, and cross-functional quality support.
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
Requirements: - Bachelor's degree in science, engineering, or related discipline
- 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
- Strong proficiency with Microsoft Office Suite (PowerPoint, Excel, Word)
Desired skills: - Advanced degree preferred
- 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
- Experience with SAP
- Ability to appropriately leverage AI tools for training content development
Pay range: up to $45.86 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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