Grifols Shared Services North America, Inc Manufacturing Supervisor in San Diego, California
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 activi-ties associated with manufacturing operations in a multi-product GMP facility. Collaborate with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, Manufacturing Science and Technology, Engineering, and Validation to accomplish organizational objectives.
Primary responsibilities for role:
Supervise the activities of production operators to ensure safe and compliant production of commercial antigens including purification and analytical testing stages.
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Develop and draft new Standard Operating Procedures (SOPs), modify or eliminate outdated/ineffective SOPs when appropriate.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.
Knowledge, Skills, and Abilities:
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 dele-gate 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.
The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs.
BA/BS degree in chemistry, biology, or related field.
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 occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 240048