Biogen

Sr Associate II, Quality Systems

Posted on: 1 Jul 2021

Research Triangle Park, NC

Job Description

Job Description

Proficient in LIMS configuration, system, and ability to serve as a subject matter expert in this arena. Supports management for activities related to interviewing/training, compliance with policies, providing feedback for personnel development, effective, technical support during audits/inspections and timely decision making/corrective actions. The Sr. Associate II should have a mature leadership approach and understanding of their personal communication style and manage that effectively.

Collaborate with business subject matter experts to define and document new or revised LabWare requirements.  Draft necessary requirement and verification/qualification documentation.  Communicate requirements and programming needs to IT and other LabWare technical developers.
Perform configuration of basic and advanced LabWare objects including, but not limited to:  Specifications, Analyses, Batch Templates, Calculations, Format Calculations, Code Snippets, Visual Workflows, Queries, and Various Templates (ELN Experiments, ELN Experiment Workbooks, Stability, Sample Login, Standards and Reagents).
Execute qualification or verification testing to support final implementation of LabWare configuration additions/revisions.
Team Lead responsibilities: Assist the LabWare business owner or QC LIMS Support Team Lead in the prioritization, scheduling, and coordination of LabWare related projects and tasks. Provide training and day-to-day support to new and existing employees. Support the identification, definition, and implementation of more efficient processes around LabWare design and change management. Assist in the development of system design standards and best practices. Communicate project status, issues, schedule, and accomplishments to various management and stakeholder groups, as needed.
Troubleshoot issues between instruments and LIMS and address complex LIMS issues by reviewing logs, code and testing in lower environments.

Qualifications

Minimally BA/BS in Life Sciences with 5+ years of relevant industry experience required.
In-depth knowledge and working experience of Labware LIMS, ELN, analytical laboratory operations, understanding quality system and directives required.
Excellent technical writing, presentation and communication skills.
Conducts approval of complex reports, data of others.
Leads complex problem solving through facilitation/escalation.
Conducts impact assessment related to compliance (global directives, audit finding/readiness, deviations).
Understanding of impact to project.
Formulates solutions/options for team and reaches out externally to regulatory/global teams/sites for alignment.
Mature leadership approach and understanding of their personal communication style and manage that effectively.
Assists in setting/reporting measurable goals & targets and mitigation plans, as appropriate.
Mentors junior members of team in quality systems, process improvements.
Leadership competencies include follow up, decision making, communication, collaboration, and innovation.

Biogen

Cambridge, MA

Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.

Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.

The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.

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