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 Diagnostic Solutions in San Diego, CA is seeking a Team Lead, Manufacturing to support TPZ manufacturing. The Team Lead role will lead and participate in manufacturing run activities including all applicable pre-production and post-production tasks required to support the full process. This position will also lead and guide manufacturing associates as necessary.

To succeed in this role, we are seeking individuals with a minimum of BS/BA in one of the biological or physical sciences with a minimum of 6 years’ experience in the biotechnology / medical devices industry and a minimum of 5 years working in a regulated environment, including 3+ years of supervisory or team leadership experience.

Responsibilities

• Responsible for all lab-related activities and area production schedule.

• 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.

• Directly participates in Bulking and Filling activities 41% of the time: material handling, folding product boxes/trays and staging of materials for process orders

• Operates and calibrates as needed all general lab equipment.

• Maintains, measures and dispenses materials for completion of Bulk formulation activities

• Perform process troubleshooting on instruments and equipment used in bulking/Filling processes

• Handling and traying of temperature-sensitive (semi-)finished goods for use in blood screening kits

• Perform in process visual inspection of temperature-sensitive (semi-)finished goods for use in blood screening kits as they come off the fill line before placement in trays.

• Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood screening kits for QC and Bio-burden.

• Receives and verifies the accuracy of materials transferred from the warehouse

• Performs labor and material transactions in the Enterprise Resource Planning (ERP) System.

• Maintains detailed and accurate device history records with cGMP and complete review and corrections in a timely manner.

• Ensure proper handling of biohazardous or infectious substances

• Ensure proper waste disposal and cleaning of facility according to SOP

• General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash.

• May be working on processes and observed during audits, including ISO, FDA and internal audits.

• Maintains and archives Manufacturing log sheet records.

• Oversee and document Change over cleaning

• Coordinate and execute applicable analytical testing activities

• 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.

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, ATLAS, and TrackWise based system knowledge a plus.

• Strong technical knowledge in commercial Purification and separation 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, including 3+ years of supervisory or team leadership experience

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 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

Ability to lift and or push 35 lbs.

PayScale

The estimated pay scale for the Team Lead, Manufacturing TPZ role based in San Diego, California is $35.12 to $43.90 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, 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. 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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 522157

Type: Regular Full-Time

Job Category: Manufacturing