Process, review and/or approve GMP, QA controlled documentation for compliance that support the development, manufacture and distribution of drug substances, drug products and finished goods produced at Biogen Idec. Responsibilities include but are not limited to:
Facilitation of the document change control process from initiation through document effectivity. Reviews and may provide final Quality approval of Standard Operating Procedures (SOP’s), Forms, Master Production Records (MPR’s), and Solution Lot Records (SLR’s) related to Manufacturing and/ or Packaging operations assuring accuracy, completeness, and compliance to internal and cGMP requirements.
Provision of QA representation and guidance at Technical Transfer meetings for manufacturing campaigns. Provide technical assistance to manufacturing operations as related to compliance requirements.
Leadership with respect to departmental projects as defined in project definition. Participate as a team lead on Global Documentation Quality system teams/projects and devise implementation plans.
Design and development of effective training modules for documentation or moderately complex processes. Provide training to Site personnel on departmental SOP’s, Quality Systems documents and Qualifying Events as related to QA. Mentors less experienced associates within Documentation function.
Lead internal/self-inspection audits to assure cGMP compliance. Provide Quality Assurance support and representation for documentation procedures during Regulatory inspections. Location US-NC-Research Triangle Park Job Category Quality Requisition Number 18992BR Qualifications - Minimum 5-8 years experience in a regulated manufacturing environment
- ASQ certification or ISPE, PDA membership (or equivalent) preferred
- Strong proficiency Microsoft Office applications
- Strong organizational skills, excellent oral and written communication skills. Basic presentation skills
- Requires a detail-oriented aptitude
- Thorough knowledge of cGMP’s and understanding of manufacturing and laboratory processes
- Thorough understanding of Quality Systems
- Knowledge of documentation systems (preferred)
- Bilingual Spanish highly desired Education Bachelors degree in a science or business discipline
Biogen (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...