Grifols Shared Services North America, Inc Supervisor, Manufacturing in Emeryville, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The Manufacturing Organization supports the Technical Operations (TechOps) business by compliantly and successfully producing antigen-based products in line with commercial cGMPs. The main responsibility for the Supervisor is to lead and oversee all functional activities associated with manufacturing operations in a multi-product GMP facility. Collaborate with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, Manufacturing Support, Technical Development, Engineering, and Validation to accomplish organizational objectives.
Supervise the activities of production operators to ensure safe and compliant production of commercial antigens.
Responsible for all regulatory compliance activities and assures group compliance to cGMP and regulatory requirements through monitoring, trending, and auditing. Ensure safety and compliance regulations are enforced.
Follow valid manufacturing procedures and documentation. Ensure batch records, logbooks, inventory forms, in-process data spreadsheets, and associated attachments are completed in a timely manner and accurately.
Ensure applicable Change Control policies and procedures are followed for new or modifications to existing facility, equipment, processes.
Investigate assigned deviations in a timely manner to identify root causes of problems and implement appropriate corrective actions to prevent from reoccurrence.
Analyze production processes and environment to identify opportunities for continuous improvement and develop a culture of operational excellence.
Develop and draft new Standard Operating Procedures (SOPs), modify or eliminate outdated/ineffective SOPs when appropriate.
Be a liaison to other Technical Operations and Quality groups promoting cross collaboration for organizational projects.
Ensure appropriate planning for successful execution of production activities
Ensure SAP transactions are being performed per agreed timeframes for different stages in the manufacturing process.
Assist in the training and development of personnel as well as evaluate the effectiveness of training and set individual and group goals.
Monitor adherence to corporate training initiatives and requirements.
Manage group budget.
Lead special projects as needed.
Key Performance Indicators:
On-time delivery in full of products (achieve target yields and reduce reject/abort lots).
Timely implementation of projects and safety/quality improvement initiatives
The number and severity of cGMP issues identified during internal and external audits/inspections
BA/BS degree in chemistry, biology, or related field. Minimum of 6+ years of GMP experience including 2+ years of supervisory or team leadership experience.
Fluent in English
Must have in-depth knowledge of commercial manufacturing.
Must have a thorough understanding of cGMPs.
Must be creative, highly organized, self-motivated, perceptive, and innovative.
Must have strong written and verbal communication skills.
Must be able to manage a diverse group of people with different strengths and skills.
Must have highly developed individual as well as team performance management skills.
Must be able to handle multiple priorities and delegate responsibilities while maintaining quality.
Must have excellent team building and project management skills
Must have direct experience with Lean, 5S, and Operational Excellence.
Must have experience with SAP including cycle counting and inventory reconciliation.
Must have experience drafting and revising SOPs as well as batch records.
Must be proficient using MS Outlook, Word, Excel, and PowerPoint.
Physical Requirements - Able to lift and push up to 20 lbs.
The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs.
Learn more about Grifols at http://www.grifols.com/es/web/international/home