The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility
Job Summary
The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.
This individual will assist with regulatory and third party audits, aid in the development and implementation of Global Quality Systems, and manage Quality projects and other initiatives.
Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.
Matching Summary
The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.
Salary
Base: $93,000.00-$121,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid vacation, Holidays, Personal Significance days, Sick time, Maternity/Parental Leave, 401(k) with match, ESPP, Tuition reimbursement
Skills & Requirements
Must-have
Quality Management Systems
cGMP compliance
Batch Record Review
Exception and CAPA management
Controlled Document Workflows
Regulatory and third party audits
Nice-to-have
Task oriented and focused on continuous improvement
Curious and eager to learn
Excellent communication and collaboration skills
Logical thinking
Mentorship and training
Key Requirements
Bachelor’s Degree in life science or Associate's Degree plus 7+ years of related experience
Minimum 5 years of relevant quality assurance experience
Experience reviewing and approving batch records, master records, SOPs and technical documents
Experience conducting and explaining investigations
Advanced understanding of global quality systems applications and GxP regulations