Manufacturing Lead - Reagent Fill

Location: 

CA-San Diego, US

Contract Type:  Regular Full-Time
Area:  Manufacturing
Req Id:  465947

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Responsible for leading the manufacturing and assembly of clinical and commercial products. This position will lead the reagent filling department at the Grifols Willow Court template-free manufacturing facility.                                                                                    

                                                           

 Primary responsibilities for role:

Provide leadership and direction to the reagent filling department.                                                                                                                                                                                                                                                                

Manage training and development of direct reports.                                                                                                                                                                                                

Oversee daily production processes and ensure all activities are completed in compliance with current GMPs and regulations.

Monitor process set-ups and run times for adherence to the manufacturing schedule.                                                                                                                                             

Ensure effective and efficient use of resources available.

Implement process improvements and drive a culture of continuous improvment.

Lead daily team huddles and represent department in meetings as required.

Assist with scheduling and coordination of production activities.

Evaluate staff and conduct performance evaluations.

Draft detailed production SLIs and participate in Production Response Teams (PRTs) as required.

Complete manufacturing batch record review and approval.

Track performance metrics and KPIs.

Ensure inventory accuracy by completing cycle counts and reviewing SAP transactions.

Initiate or complete QN investigations as needed.                                                                                                                                                                                                      

Draft product test plans and planned deviations.

Responsible for maintaining the controlled environment in reagent filling areas.

Recommend updates to batch records and SOPs.

Conduct GMP, safety and housekeeping audits.                                                                                                                                                                                                        

Act as a backup to the area supervisor as needed.

 

Additional Responsibilities:

Monitors team training files and area logbooks; Audits routings and BOMs; Identifies document improvements; Investigates labor and material variances; Acts as a liaison with other departments; Assist with transfer of products and processes into manufacturing; Provides updates as applicable; Provides team and individual directives; Reports delays to scheduled tasks; Approves/rejects timesheets; Performs periodic review of SOPs; Follows all safety rules; Maintains accurate and complete training records; understands and executes written procedures in accordance with cGMPs; operates basic filling equipment; maintains detailed and accurate device history records; Monitors inventories for accuracy;                                                                                                                                                                                                                                                                                                                                                              

                                                           

 

Knowledge, Skills, and Abilities:

• Must have strong leadership skills.                                                                                                                                                                                                                                      • Must be able to manage a diverse group of people with different strengths and skills.

• Must have strong written and verbal communication skills.

• Must have direct experience with Lean, 5S, and Operational Excellence.

• Must have a thorough understanding of cGMPs.

• Must have developed individual and team performance management skills.

• Must have in-depth knowledge of Filling Processes and concepts.

• Must have experience with SAP including cycle counting and inventory reconciliation.

• Must be creative, highly organized, self-motivated, perceptive, and innovative.

• 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:

Typically requires High school diploma and 6 + years related experience or AA and 2-4 year related experience or BS and 0-2years related 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 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:

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to

10 pounds in weight frequently or continuously.

 

                                                 

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

 

Learn more about Grifols

 


Nearest Major Market: San Diego