Sr. Associate II, Quality Assurance

Biogen•Research Triangle Park, NC

3d•$93,000 - $121,000•Onsite

About The Position

This is a full time on-site position with M-F business hours About This Role 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 has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures. 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. What You’ll Do Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact. Conduct investigations, perform thorough reviews of investigations, and provide feedback to the department owner. Support investigations with the ability to analyze the defect and determine potential areas within the process that may have attributed to the defect. Writes and/or reviews, and approves minor and major deviations Lead, coordinate, and ensure timely completion of Annual Product Reviews. Participate in cross-functional risk assessments to identify, evaluate, and mitigate risks to product quality, patient safety, and regulatory compliance Establishes and maintains data integrity governance aligned with ALCOA+ principles. Performs data integrity risk assessments for manufacturing, laboratory, and quality systems. Ensures data lifecycle management from data generation through archival and retrieval. Develop and deliver data integrity and GMP training to personnel across functions. Promote a culture of quality and data integrity awareness throughout the organization. Monitor regulatory trends and guidance related to data integrity and incorporate best practices Batch Record Review and Product Disposition: this role may perform review of Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, etc.) for compliance and determine acceptability for use in GMP production activities and/or release of product for further processing and/or distribution Complete area walkthroughs and work observations to identify compliance gaps. Collaborate with Manufacturing and Area Subject Matter Experts to identify appropriate corrective actions Support resolution of both technical and compliance issues/gaps of moderate complexity. Help in implementation of Quality Systems/System Improvements and technical problem solving Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions. Other duties as assigned Who You Are You are task oriented and focused on continuous improvement. You are curious and eager to learn. You ask copious questions and excel at root cause analysis. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.

Requirements

Bachelor’s Degree, preferred in life science. Can consider Associate's Degree plus 7+ years of related experience
Minimum 5 years of relevant quality assurance experience within a GMP pharmaceutical or biotech manufacturing environment
Experience reviewing and approving batch records, master records, SOPs and technical documents
Deep understanding of data integrity
Experience conducting and explaining investigations to quality management and regulatory bodies
Experience working on the floor within manufacturing environment, either as QA oversight or manufacturing operator
Advanced understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations
Must be able to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
Excellent written, verbal, and interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations and decisions to Quality Management and regulatory bodies, develop strong networks cross-functionally to drive collaboration, processes and decisions

Nice To Haves

Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule)
Experience supporting product disposition
Experience conducting and explaining investigations to quality management and regulatory bodies is strongly preferred

Responsibilities

Assess criticality of exceptions/investigations for product impact.
Conduct investigations, perform thorough reviews of investigations, and provide feedback to the department owner.
Support investigations with the ability to analyze the defect and determine potential areas within the process that may have attributed to the defect.
Writes and/or reviews, and approves minor and major deviations
Lead, coordinate, and ensure timely completion of Annual Product Reviews.
Participate in cross-functional risk assessments to identify, evaluate, and mitigate risks to product quality, patient safety, and regulatory compliance
Establishes and maintains data integrity governance aligned with ALCOA+ principles.
Performs data integrity risk assessments for manufacturing, laboratory, and quality systems.
Ensures data lifecycle management from data generation through archival and retrieval.
Develop and deliver data integrity and GMP training to personnel across functions.
Promote a culture of quality and data integrity awareness throughout the organization.
Monitor regulatory trends and guidance related to data integrity and incorporate best practices
this role may perform review of Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, etc.) for compliance and determine acceptability for use in GMP production activities and/or release of product for further processing and/or distribution
Complete area walkthroughs and work observations to identify compliance gaps.
Collaborate with Manufacturing and Area Subject Matter Experts to identify appropriate corrective actions
Support resolution of both technical and compliance issues/gaps of moderate complexity.
Help in implementation of Quality Systems/System Improvements and technical problem solving
Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen
Support and/or assist in GxP quality systems-related training.
Provide some mentorship and training within and across functions.
Other duties as assigned

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation