Senior Quality Assurance Specialist (QA Operations)

Wave Life Sciences • Lexington, MA

3d • Onsite

About The Position

The Senior Quality Assurance Specialist will provide Quality Assurance (QA) oversight and support to Manufacturing, Quality Control, and Process Development, Technical services and other teams for both onsite or externalized manufacturing and testing, technology transfer, and other CMC development activities.

Requirements

• Bachelor’s degree in biology, chemistry, or a similar scientific field
• 8-10+ years of work experience working in or with a GMP organization
• Experience with QMS, LIMS, ERP and other systems
• Experience with batch record review and QC review
• Experience with Raw Material inspection, release and labeling
• Experience with root cause investigation and risk assessment
• Experience with cGMPs and ICH regulations for drug development
• Proficient with MS Word, Excel, and Outlook
• Effective written and verbal communication skills
• Superior attention to detail, strong organizational skills and the ability to multi-task and work effectively in a highly-collaborative, cross-functional, fast- paced environment
• Critical thinking, curiosity, and ability to learn independently
• Ability to influence, debate, and consider multiple perspectives
• Work harmoniously with other functional areas and stakeholders

Nice To Haves

• Technology transfer (process and analytical methods) experience preferred
• Experience with Drug Substance, Drug Product, and Finished Goods (label/pack) operations
• Experience working collaboratively with CMOs is preferred
• Understanding of CMC development

Responsibilities

• Review batch records, testing records, logs, and other documentation to ensure compliance to GDPs and governing SOPs
• Release and label raw materials
• Review and approve stability and validation protocols, data and reports to ensure compliance with internal procedures and industry guidelines
• Disposition raw materials, drug substance, drug product, and finished goods
• Collaborate with Manufacturing to resolve equipment and process issues
• Review and approve work orders for GMP facilities and equipment
• QA review and approval of QS records (Deviations, CAPA, Change Controls, Risk Assessments, etc.)
• Lead and perform investigations independently (deviations, OOS/OOT, SCARs, etc.)
• Author/Revise/Review SOPs, Training Guides/Aides, and protocols as Quality SME
• Work with applicable groups towards process improvements; including but not limited to Quality Systems improvements in support of preclinical, clinical, and commercial product development
• Quality representative on project initiatives
• Support audits of Wave and Regulatory Inspections
• Occasional support of supplier and internal audits
• On-site presence for minimum 4 days a week
• Other duties as assigned

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• 401K participation with matching contributions
• Employee Stock Purchase Program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior