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.
Grifols Diagnostics Solutions Inc is seeking a Team Lead, Manufacturing in San Diego, CA. The Team Lead role will lead the Immunohematology manufacturing activities including all applicable pre-production and post-production tasks required to support the full process. This position will also provide leadership and guidance to other manufacturing associates assigned to the applicable run. The Team Lead, Manufacturing will focus on fill/finish manufacturing and leading a team of Reagent Bulk, Fill and Packaging Technicians.
We are seeking individuals with expertise in Immunohematology related manufacturing, team leadership, with at least a Bachelors in biological or physical sciences and at least 6 years of experience in the biotechnology/medical device industry. At least 5 years of experience supporting a GMP environment.
Shift Requirement: Variable shifts
Responsibilities:
Guide and lead the work of department associates executing daily operations.
Act as a point of contact for the production of an assigned run from start to finish.
Assign production support activities to other associates in accordance with the schedule.
Ensure that all production operations are conducted in full compliance with Grifols policies, regulatory (GMP, FDA, ISO) and safety requirements.
Coordinate pre-production checks and activities as required
Troubleshoot and resolve applicable technical issues encountered in the process
Coordinate and execute applicable analytical testing activities
Assist with batch record review and corrections as required
Review, initiate, and approve change requests for the department.
Initiate production related deviations in the associated quality system
Manage assigned investigations as required including the implementation of corrective actions.
Own and manage assigned corrective/preventative (CAPA) actions in the associated quality system.
Coaching and mentoring whenever necessary, foster positive, result-driven teamwork environment.
Can perform supervisory activities as needed or as assigned
Knowledge, Skills, and Abilities:
Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements. Computer skills are required (Word, Excel, Outlook). SAP, knowledge a plus.
Strong technical knowledge in commercial Immunohematology techniques.
Strong troubleshooting abilities including process monitoring to identify opportunities for continuous improvement.
Strong interpersonal and cross functional team building skills
Must have experience supporting and/or leading deviation investigations.
Excellent communication skills, organizational skills, writing and problem solving skills required.
Must be able to work independently and make critical decisions.
Must establish proper priorities and manage time and available resources.
Must be able to establish and maintain effective working relationships with customers and co-workers.
Understand the operation of all equipment associated with the process being supervised.
Understand GMP, FDA and ISO regulatory requirements.
5S, Lean manufacturing knowledge a plus.
Strong organization and time management skills, with the ability to prioritize and get activities completed on-time.
Established troubleshooting abilities including process monitoring
Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements
Education:
Minimum requirements: BS/BA in one of the biological or physical sciences
Experience:
Minimum of 6 years' experience in the biotechnology / medical devices industry and a minimum of 5 years working in a regulated environment.
Minimum 2 years of leadership experience in a regulated immunohematology or similar biological-based manufacturing environment.
Equivalency:
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 state requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience, or a bachelor's degree.
Occupational Demands:
Ability to lift and or push 35 lbs
The estimated pay scale for Team Lead Manufacturing - Variable Shift role based in San Diego,CA is $40.69 to $50.87 per hour. 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, life insurance, PTO, paid holidays and 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. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
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.
Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 549243
Type: Regular Full-Time
Job Category: MANUFACTURING
