QA Associate – Equipment Qualification & GMP Review

Job Title: QA Associate – Equipment Qualification & GMP Review
Location: Wayne, PA 19087
Contract Duration: 1 year (Possibilities of EXtension)

Work Hours: 9:00 AM – 5:00 PM (Onsite)
 
Role Summary:
The QA team is responsible for reviewing qualifications and GMP documentation for equipment validation. The role involves reviewing, editing, and ensuring compliance with GMP guidelines across various lab activities, including assay development and other processes.
 
Key Responsibilities:

• Review and edit GMP documents, including guidelines and equipment qualification records.
• Ensure attention to detail and accuracy in documentation; no corrections or deviations should be overlooked.
• Provide training to team members on equipment-related tasks and work orders.
• Manage long-term projects and review best practices in lab processes.
• Perform tasks urgently when requested.
• Build reports based on review outcomes.

 
Skills & Tools Required:

• Strong knowledge of GMP practices in a lab setting.
• Experience in assay development and general lab operations.
• Proficient in MS Word and Excel.
• Attention to detail and ability to manage multiple priorities.
• Ability to review and analyze technical documents and work orders.

 
Qualifications:

• Bachelor’s degree in biology or a related field.
• Candidates with ongoing bachelor’s degrees may also be considered.
• Experience: 1–3 years in GMP lab operations preferred.

 
Training:

• Initial training includes a variety of tasks; typically, less than a week for work order and equipment-related tasks.
• Full integration into the team generally takes 1–1.5 months.

 
Interview Details:

• In-person interview in Wayne, PA.
• Two interviewers, approximately 45 minutes.