Team Lead, Manufacturing TPZ

GRIFOLS, S.A.•San Diego, CA

3d•$35 - $44•Onsite

About The Position

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.

Requirements

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.
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
Minimum requirements: BS/BA in one of the biological or physical sciences
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

Nice To Haves

5S, Lean manufacturing knowledge a plus.

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 80% 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.