Associate QA - Onsite

Aptask Global Workforce (AGW) is seeking an Associate QA for an Onsite position with a Global Biotechnology Company located in New Albany, OH. This is a 12+ month contract opportunity.

This role involves working in a shift system to provide Quality Assurance guidance and support to production operations. The main responsibilities include performing Quality Batch Record Reviews for all commercial batches and establishing effective working relationships with various stakeholders across production, warehouse, and engineering departments. This position requires flexibility for 12-hour shifts, which may fluctuate and include overnight hours (6:00 PM - 6:30 AM).

Responsibilities:

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions
• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems
• Act as a first point of contact for quality-related production queries during packaging and labeling operations
• Review and approve batch production records and other GMP documentation in support of daily operations
• Perform finished product checks during commercial production runs
• Compile and review batch records for lots assembled, packaged, and labeled in preparation for batch disposition
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions, and Forms
• Review and approve Deviation, CAPA, and Change Control records
• Adhere to safety rules and maintain a safe work environment

Requirements:

• High school diploma/GED with 2+ years of work experience, OR an Associate's degree with 6+ months of work experience, OR a Bachelor's degree
• GMP experience or exposure
• Strong attention to detail
• Team-oriented mindset
• Must have flexibility with 12-hour shifts, including potential overnight shifts

Desired skills:

• Experience with Veeva, Trackwise, SAP, Maximo, and MES
• A scientific background or relevant experience

Pay range: up to $25.46 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.