Specialist Product Quality

Aptask Global Workforce (AGW) is seeking a Specialist Product Quality for a Remote position with a Global Biotechnology Company. This is a 36 month contract opportunity.

This is an individual contributor role that provides critical support to Product Quality Teams by managing stability programs for late-stage clinical and commercial products. The successful candidate will serve as a primary author of regulatory filing sections, organize and analyze product quality and stability data, and support GMP inspections. This role requires strong expertise in GMP compliance, data management, and cross-functional collaboration, and involves contributing to business process improvements by authoring SOPs and supporting electronic data management tools.

Responsibilities:

• Build, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)
• Author and maintain GMP technical documents and stability reports in compliant systems
• Provide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)
• Collate, review, verify, and archive GMP stability and product quality data
• Coordinate stability study starts and sample requests with global teams
• Participate in audits and inspections across multiple sites, ensuring readiness and compliance
• Collaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor Changes
• Mentor and train staff, sharing expertise to strengthen team capabilities

Requirements:

• Doctorate Degree in a Life Sciences or Engineering discipline OR
• Master's degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor's degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience
• Thorough understanding of GMP requirements, US FDA, and ICH regulations
• Strong scientific data management and organizational skills with exceptional attention to detail
• Proven technical writing skills with ability to author regulatory-quality documents
• Ability to deliver accurate results on time within GMP quality systems (Veeva, LIMS, Spotfire)
• Excellent written and verbal communication skills across all levels of the organization, with the ability to build cross-functional relationships
• Proven ability to work independently and manage time-sensitive activities across teams
• Continuous improvement mindset with experience applying lean practices
• Proficiency in MS Office (Word, Excel, PowerPoint, Teams)

Desired skills:

• Experience managing GMP stability programs for pharmaceutical products in compliance with FDA and ICH regulations
• Experience with authoring, assembling, and reviewing annual product reviews
• Expertise in GMP applications (Veeva, Spotfire, SHINY)
• Experience collaborating across time zones in a global, matrixed team environment
• Strong analytical and problem-solving mindset
• Strong initiative and self-motivation to drive results under pressure
• Team-oriented approach with a focus on achieving shared goals
• Strong presentation and public speaking skills for inspections and cross-team updates

Pay range: up to $35.50 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.