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Manufacturing Team Supervisor
2 months ago
Are you interested in becoming part of a global team dedicated to advancing healthcare solutions? Grifols is a prominent healthcare organization that has been committed to enhancing the health and wellness of individuals worldwide since 1909. We excel in the field of plasma-derived therapies and transfusion medicine, providing innovative products and services across over 110 countries.
Position Overview:
Grifols Diagnostics Solutions Inc is looking for a Team Lead, Manufacturing to join our team in San Diego, CA. This leadership role is responsible for overseeing manufacturing operations, including all necessary pre-production and post-production activities to ensure a seamless process. The Team Lead will also mentor and guide other manufacturing personnel involved in the production runs. Please refer to the specific department Task List for further details.
Shift Requirements: Flexible shifts
Key Responsibilities:
- Direct and support the efforts of department associates in daily operational tasks.
- Serve as the primary contact for the production of designated antigen runs from initiation to completion.
- Delegate production support tasks to team members in alignment with the operational schedule.
- Ensure adherence to Grifols policies, as well as regulatory (GMP, FDA, ISO) and safety standards throughout all production activities.
- Oversee pre-production checks and necessary preparations.
- Identify and resolve technical challenges encountered during the production process.
- Coordinate and conduct relevant analytical testing as required.
- Assist in the review and correction of batch records as needed.
- Review, initiate, and authorize change requests for the department.
- Initiate production-related deviations within the quality management system.
- Manage investigations as necessary, including implementing corrective actions.
- Oversee and manage assigned corrective/preventative actions (CAPA) within the quality system.
- Provide coaching and mentorship to foster a collaborative and results-oriented team environment.
- Perform supervisory duties as needed or assigned.
- Comprehensive knowledge of cGMPs, including equipment, technology, and quality system requirements. Proficiency in computer applications (Word, Excel, Outlook) is essential. Familiarity with SAP, ATLAS, and TrackWise systems is advantageous.
- Strong technical expertise in commercial purification and separation methodologies.
- Proficient troubleshooting skills, with the ability to monitor processes and identify opportunities for continuous improvement.
- Excellent interpersonal skills and ability to build cross-functional teams.
- Experience in supporting and/or leading deviation investigations is required.
- Exceptional communication, organizational, writing, and problem-solving skills are necessary.
- Ability to work independently and make critical decisions.
- Strong prioritization and time management skills to effectively manage resources.
- Ability to establish and maintain effective working relationships with colleagues and stakeholders.
- Understanding of all equipment related to the supervised processes.
- Familiarity with GMP, FDA, and ISO regulatory standards.
- Knowledge of 5S and Lean manufacturing principles is a plus.
- Demonstrated organizational and time management skills, with the ability to prioritize tasks effectively.
- Thorough understanding of cGMPs, including equipment, technology, and quality system requirements.
Minimum qualifications include a BS/BA in a biological or physical science.
Experience:
A minimum of 6 years of experience in the biotechnology or medical device sector, with at least 5 years in a regulated environment.
Physical Requirements:
• Ability to lift and/or push up to 35 lbs.
Compensation:
The estimated pay range for this Team Lead, Manufacturing position in San Diego, California is $38.88 to $48.60 per hour. Additionally, the role is eligible for participation in the company bonus program. We offer a comprehensive benefits package, including medical, dental, vision, paid time off, a 401(K) match, and tuition reimbursement. Final compensation will be determined based on education, experience, skills, knowledge, and internal equity. Grifols is dedicated to providing opportunities for professional development and career advancement. Our organization has grown significantly over the past decade, and we invite you to grow with us.