Sr. Associate I, Quality Control Systems (Analytical Instrument Validation) at Biogen in Research Triangle Park, North Carolina

Job Description:

Job Description

This is a full time, on site position with M-F business hours

About This Role 

The Sr. Associate I position will serve within the Global QC Instrument and Equipment Strategy team. The Global QC Instrument and Equipment Strategy team is responsible for: (1) leading the harmonization effort of QC and MFG analytical equipment and instrument systems across sites, (2) providing project management oversight for qualification, validation, decommissioning, and integration with computer systems for instruments and equipment, (3) supporting system administration activities during validation and serve as back-up system administrator (when designated) when system is released for production use, (4) managing the annual CAPEX budgeting and purchasing process, and (5) overseeing the lifecycle management of QC and MFG instruments and equipment.  The Sr. Associate I will coordinate projects & deliverables, and ensure proper administration and adherence to all Biogen policies and procedures. Additional responsibilities include writing and reviewing technical documents, scheduling, and balancing of workload with respect to equipment / instrument availability, prioritization of projects, adherence to all regulatory licenses and regulations, interfacing with key Quality, IT, validation, metrology, & vendor representatives, writing/coordination and review of operation, maintenance, and system administration procedures for all QC and MFG analytical equipment/instrumentation. 

WhatYou'llDo 

• Lead validation/qualification projects for QC laboratory and MFG equipment, instruments, software applications and computer systems per applicable procedures. Utilize in-depth/technical knowledge to review, approve, and execute system life cycle documentation including VP, RRA, RS, IOPQ protocols, decommissioning protocols, other compliance related protocols/reports, change control requests, validation protocols/reports as applicable. 


• Assist with and plan training for team and supports completion of projects to milestones. 


• Ensure compliance with platform, procedures and Global QC vision (global harmonization). 


• Plan, implement and direct core functions of teams related to equipment/instrument purchase (eCAF and Purchase Requisitions), maintenance, and implementation or decommissioning projects; provide system administration support during validation, technical support during routine use, as well as facilitation of investigations/compliance tasks.   


• Coordinate QC support activities/projects related to instrumentation/equipment with other departments & key contacts (internally/externally); provide updates to QC management. 


• Support and help to design effective laboratory systems/life cycle to ensure system/data integrity of all laboratory instrumentation/equipment programs.  


• Participate in a leadership or membership role for site cross-functional teams as a representative of the QC laboratories. 


• Provides technical guidance to document authors (junior team members, QC lab SMEs, or consultants). 


• Other duties as assigned

Qualifications

Required Skills

• Bachelor's degree in Life Science, Computer Science or Engineering with a minimum of 4 years of quality experience in a pharmaceutical or biotech manufacturing environment


• Technical knowledge regarding QC analytical equipment and instrument systems, lab methodology (as appropriate)


• Demonstrated strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively; strong organizational and project management skills; ability to multi-task and coordinate multiple activities in parallel; demonstrated problem solving skills; demonstrated instrument/computer system troubleshooting skills.   


• Knowledge of FDA/EMEA regulations including 21CFR parts 210/211 (GMP), EudraLex Vol. 4 (EU GMP), 21CFR Part 11, Annex 11   


• Skilled in validation lifecycle (CSV, SDLC) documentation creation and review, including: GxP Assessments, Validation Plans, Risk Assessments, Data Integrity Assessments, Requirements/Design Specifications, IQ/OQ/PQ Protocols, Reports, and Standard Operating Procedures (SOPs)


• Experience with managing the periodic and preventative maintenance of equipment/instruments and maintaining the validated state of analytical equipment and instruments through change control and regularly scheduled periodic review


• Knowledge of Data Integrity principles

Preferred Skills

• Working knowledge of GAMP 5 for GxP Computerized Systems and/or USP <1058> Analytical Instrument Qualification


• Experience with QUMAS DocCompliance, KNEAT, TrackWise, NuGenesis SDMS, MS Sharepoint


• Familiarity with lab applications such as LabWare LIMS, Empower CDS, and vendor-supplied instrument control and data analysis software commonly used in QC laboratories in the pharmaceutical industry

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

 

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