Grifols Shared Services North America, Inc Manager, Manufacturing in San Diego, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
This position will be responsible for managing the overall activities associated with manufacturing operations in a multi-product GMP facility. Lead and manage all functional activities associated with the respective stages of manufacturing in DNA Synthesis/Purification and Bulk Formulations areas. Partner with key departments to ensure reliable, safe and compliant operations.
Primary responsibilities for role:
Manage department activities to ensure products are manufactured and delivered in a timely manner.
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.
Works directly with Planning to develop and implement Master Production schedules as needed to meet demand and maintain supplies of materials/reagents required to meet manufacturing schedules.
Investigate all deviations in a timely manner to identify root causes of problems and implement appropriate corrective actions to prevent from reoccurrence.
Provide leadership to generate support and effectiveness throughout the organization. Also, provide leadership for group and work with the staff to assist in the training of personnel as well as evaluate the effectiveness of training and set individual and group goals.
Ensure batch records, logbooks, inventory forms, and associated attachments are completed accurately and in a timely manner. Ensures inventory transactions are performed and inventory is stored properly.
Responsible for department staff scheduling to include: department meetings, work assignments/rotations, employee training, employee vacations, employee breaks, overtime assignment, back-up for absent employees and performance evaluations
Must have direct experience with Lean, 5S, and Operational Excellence.
Evaluates long-term capacity plans and makes recommendations on new equipment needs, etc.
Must be creative, highly organized, detail-oriented, self-motivated, perceptive, and innovative.
Must have strong written and communication skills.
Must be able to manage diverse group of people with different strengths and skills, and have excellent team building and project management skills
Must be able to handle multiple tasks and delegate responsibilities while maintaining quality.
Must have knowledge of manufacturing processes and systems and a thorough understanding of cGMP. Experience in drafting and revising Work Instructions, SOP’s and batch records a plus.
Must have experience with ERP systems as well as cycle counting and inventory reconciliation.
Knowledge, Skills, and Abilities:
Decision-Making skills, Interpersonal skills, Judgment Problem Solving skills. May participate on Core teams.
Working knowledge of chemistry, biochemistry, laboratory safety, mathematics, and federal QSRs. Working knowledge of GMPs and ISO 9001 regulations.
Knowledgeable of MS WORD, EXCEL, POWERPOINT
Typically requires BA or BS
Eight to ten years of 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.
May be able to lift up to 5 lbs. as required.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 73530
Type: Regular Full-Time
Job Category: Manufacturing