Kelly Engineering Resources® specializes in providing companies around the world with qualified engineers, designers, drafters and technicians. We are part of Kelly Services®, a US-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Job Responsibilities -Review and Approval of GMP design and qualification Lifecycle documents (e.g. URS, impact assessments, IOQs, PQs) - 70% -Review and Approval of GMP operations documents such as batch records - 10% -General QA support and guidance on quality issues and adherence to internal quality procedures and policies. - 10% -Support of quality systems execution (e.g. Deviations, CAPAS, Investigations, etc) - 10%
'A minimum of a B.A. degree (science preferred) with at least 5 years relevant experience executing or developing GMP quality programs in cGMP biotech and/or pharmaceutical environments. 'Pharmaceutical quality assurance experience (biopharmaceutical a plus) 'Previous experience in other Quality Assurance and/or Validation functions is a plus. 'Quality assurance or validation role on a new pharmaceutical facility project a plus. 'Bioreactor and disposables experience a plus 'Experience with TrackWise for quality systems.
'Flexible 'Ability to work effectively in a fast-paced environment 'Strong written and oral communication skills required 'Excellent interpersonal skills required 'Adherence to domestic and international GMP regulations, cGMP's, company policies 'Teamwork skills essential 'Strong organizational skills 'Ability to multi-task in a dynamic environment with changing priorities 'Strong work ethic 'Ability to meet challenging timelines, in spite of obstacles, within budget 'Strong prioritization skills
'This individual will be expected to make decisions on quality related questions or issues that are in line with company's procedures and policies. 'It is incumbent upon this individual to bring any concerns to direct supervisor or areas of significant cross- functional disagreement to supervisor.
Besides working closely with the QA Operations Group, this individual will work closely with the following groups: oManufacturing oFacilities and Engineering oValidation
'Weekend and off hours work may be required. 'Will be required to wear appropriate Personal Protective Equipment in construction areas and appropriate gowning in manufacturing clean areas as needed.
The recruiting team of Kelly Engineering Resources is actively reviewing resumes received through the online application process. To be considered for this position, as well as future opportunities, please click the 'Apply Now' button and submit your resume. We invite you to bookmark our website and encourage you to review it regularly for new opportunities worldwide: www.kellyengineering.com Kelly Services- Celebrating 60 Years