Grifols Shared Services North America, Inc Manager, Technical Services 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 produces antigen-based products in line with commercial cGMPs. The main responsibility for the Technical Services Manager is to lead and oversee all functional activities associated with the Technical Services (Reagent Preparation and Glassware) operations in a multi-product GMP facility. The Technical Services area supports the upstream and downstream manufacturing groups. In addition, this position will collaborate with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, Manufacturing Support, Engineering, and Validation to accomplish organizational objectives.
Primary responsibilities for role:
Manage the overall Technical Services department activities to ensure products are manufactured and delivered in accordance with the production schedule.
Manage the contracted cleaning crew that supports the entire manufacturing area.
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 production records, logbooks, controlled forms, and associated attachments are completed accurately and in line with expected production schedule.
Ensure that when appropriate, Change Control policies are followed for new and/or modifications to existing facility, equipment, processes and procedures.
Support area deviation investigations by supplying necessary process or production related information. Take ownership of the deviation root cause metrics for the area. Implement appropriate corrective actions to prevent deviation reoccurrence.
Monitor solution preparation and glassware areas to identify opportunities for continuous improvement to develop a culture of operational excellence.
Provides overall leadership to the Technical Services area by setting area goals and ensuring there is effective feedback and communication within the department.
Monitors the adherence to all internal and corporate trainings. Attends and partici-pates in Internal Audits and external audits.
Directly responsible for the Technical Services area staff performance and career de-velopment.
Develop and draft new department policies or procedures, modify or eliminate out-dated ineffective policies when appropriate.
Be a liaison with QA, QC and other manufacturing groups maintaining responsibility for all antigens produced.
Manage department budget.
Lead special projects as needed.
Knowledge, Skills, and Abilities:
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
Preferred direct experience with Lean, 5S, and Operational Excellence.
Preferred 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 40 lbs.
Must be flexible and willing to work evenings and weekends based on the production schedule needs.
BA/BS/MS degree in chemistry, biology, engineering or related field.
Minimum of 6+ years of GMP experience including 3 years of supervisory or team leadership experience
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home