Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary:
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.
The Supervisor may work in any one of the following Manufacturing departments: Fermentation, Purification, Bulk Fill, Peptide Synthesis, or Technical Services. Refer to the associated department-specific Task List for additional requirements.
Primary Responsibilities:
Supervise the activities of production operators to ensure safe and compliant produc-tion 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 continu-ous 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Develop and draft new Standard Operating Procedures (SOPs), modify or eliminate outdated/ineffective SOPs when appropriate.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 col-laboration 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 man-agement 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.
Education and Experience:
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.
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.
Occupational Demands: Physical Requirements - Able to lift and push up to 20 lbs.
This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned.
BENEFITS
The estimated pay scale for the Supervisor, Manufacturing role based in Vista, CA is $86,198.25 - 129,296.80 annually depending on experience
Additionally, the position is eligible to participate in up to 5% of the company bonus pool
We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement
Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
California Personnel Privacy Policy and Notice at Collection
Location: NORTH AMERICA : USA : CA-Vista:[[cust_building]]
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 539880
Type: Regular Full-Time
Job Category: MANUFACTURING
