Grifols Shared Services North America, Inc QC Manager in emeryville, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
The Manager will direct the day to day to day operations of one of the Grifols Diagnostic Solutions Quality Control Laboratories which consist of: Method Validation, Antigen Release and Stability, QC Raw Materials (QCRM), QC Microbial (including seedstock) and QC Equipment/eSystems programs. The senior Manager will work with Engineering, Validation and Manufacturing Sciences and Technology (MS&T) groups to schedule any QC testing. May direct the work of other QC managers and associates to examine and define QC processes that can be streamlined and improved.
Primary Responsibilities for Role
Direct the day to day operation of one of the QC laboratories. Manage a staff of approximately 10 – 15 individuals responsible for Method Validation, Seed Stock manufacturing, Equipment/eSystems as well as in-process, final product (antigens), stability, reference qualification, in-process, cleaning validation and product development (MS&T) testing functions. The Manager will also be responsible for investigating OOS/OOT/OOE deviations in their designated functional area, ensuring that DRs and CAPAs are submitted to QA for closure on time.
Owns the procedures that govern their assigned functional area and ensures that all documents are approved and in alignment with the applicable Grifols Quality Standards
Ensure that their designated QC laboratory provide on time testing
Ensure that Bacterial and Yeast Seed Stocks are manufactured and released as required
Address any antigen and Seed Stock stability protocol or stability results deviations and escalate to Quality Head as appropriate
Oversee laboratory investigations in their assigned area
Execute OE projects such as 5S, Value Stream Mapping (VSM), “Role Cards”, “Level and Flow”, “Standard” work for their assigned QC processes
Select, train and develop staff so that they realize their full potential and work in conformance to company policies relating to environmental protection, health and safety at work.
Work with Site Environmental Health & Safety (EH&S) representatives to ensure that their assigned QC laboratory adheres to Grifols EH&S standards, requirements and best practices
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Timely release testing for all antigen product lines, seedstocks
Timely release testing for RMs
Completion of antigen and SeedStock stability test intervals and reports within the required times
Completion of Method Validations and Method Validation evaluations
Completion of onboarding of new equipment
Investigation and closure of DRs and closure of CAPAs within the required time
OOS and QC related DRs defended to regulatory agencies during product review or site inspections.
The number and severity of GMP issues identified during internal and external audits related to their assigned laboratory functions.
Efficiency of assigned laboratory operations.
No safety incidents or HSE related observations.
Knowledge, Skills, and Abilities
Must be experienced in one of the main areas listed:
Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits. Experience in assay validation/development/transfer and assay trouble shooting.
Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Growth Promotion. Must also be familiar with the development, manufacture and testing of Bacterial and Yeast Seedstocks.
Environmental/Utility/facility Monitoring programs, with knowledge of area classifications and required environmental monitoring as well as manufacturing water systems and required quality testing requirements
Analytical/Microbiological Method Validation, assay development/transfer and assay trouble shooting
Pharmacoepeial (compendial) test methods for Raw Materials
Equipment installation and qualification, electronic systems (LIMS, paperless laboratory systems) and eCompliance
Experience with investigations
Strong scientific analytical and writing skills, proficient in MS Word, MS Powerpoint and MS Excel software
Must be familiar with GMP's and Quality System Regulations (QS Regs) and practical judgment in the interpretation and application of regulations and standards specific to the Quality Control laboratory
Experience working with FDA licensed biologics FDA inspections.
Must be able to think abstractly about data and be able to work with a team toward shared goals.
Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.
Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.
Must meet the six (6) mission critical competencies listed below:
Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesn’t show frustration when resisted or blocked; is a settling influence in a crisis.
Is bright and intelligent; deals with concepts and complexity comfortably; described as intellectually sharp, capable, and agile.
Is effective in a variety of formal presentation settings: one-on-one, small and large groups, with peers, direct reports, and bosses; is effective both inside and outside the organization, on both cool data and hot and controversial topics; commands attention and can manage group process during the presentation; can change tactics midstream when something isn’t working.
Is easy to approach and talk to; spends the extra effort to put others at ease; can be warm, pleasant, and gracious; is sensitive to and patient with the interpersonal anxieties of others; builds rapport well; is a good listener; is an early knower; getting informal and incomplete information in time to do something about it.
- Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 6 years or MS/PhD degree in science with 4 plus years.
- At least 6 years experience in a regulated GMP testing laboratory with 4 years in a supervisor level position.
- 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.
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.
Learn more about Grifols
Req ID: 121667
Type: Regular Full-Time
Job Category: Quality