Grifols Shared Services North America, Inc QC Support Analyst 4 in San Diego, California
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.
To provide expertise to their designated QC group, perform routine material release testing and to accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines. Use experience in specific job area for all analytical assay method training to coordinate and perform critical material qualification, date extension justification, material trend analysis and/or other projects that are in addition to typical release, qualification and/or stability testing.
Primary responsibilities for role:
Execute Date Extension Protocol Testing, write routine date extension reports
Write cojent process deviation nonconformance investigations
Train new QC employees in a specific area of expertise.
Execute thorough lab investigations using root cause analysis.
Responsible for the maintenance, testing, and communication of at least one product line or technical area in QC.
Method Development: Responsible for executing testing for the QC Method Development group. May be responsible for Protocol and Report writing dependent upon the level of complexity.
Perform assays for their designated laboratory:
QC Functional testing, on multiple automated and manual platforms for release of raw materials, in process, and final product. Trained in QC Ancillary assays such as T7 Enzyme Activity, RT Polymerase Assay, Complement Chemiluminescense testing.
QC Microbiology testing, microbiological testing for release of product, sterility testing, growth promotion testing, microbial identification, environmental monitoring.
QC Analytical testing for release of Raw Materials, sub-assembly material product, and fi-nal product.
Perform testing supporting the QC Stability program.
Cleaning and or Process Validation testing
Analytical Method Validation testing
Product/Method development testing
General Laboratory Responsibilities”
Maintenance and cleanliness of QC equipment, ensuring equipment is within calibration, submitting items for calibration as needed
Maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials
Completing training in a timely manner and maintaining the records.
Comply Site Environmental Health & Safety (EH&S) requirements
Knowledge, Skills, and Abilities:
Timely execution and completion of release and stability testing for all Procleix product lines
Timely execution of requested date extensions.
Timely execution and completion of testing for RMs
Training in new assays within the required time
Training of QC analysts on assays within the required time
No safety incidents or HSE related observations.
Bachelor’s degree in Biochemistry, Molecular Biology, Immunology, or Microbiology with 3-5 years or MS degree in science with at least 1 year experience.
At least 3 years experience in a regulated GMP testing laboratory
Must have proficiency in three or more methods in one of the main areas listed:
o Analytical Test Methods using HPLC, Mass Spectroscopy, Ion Chromatography, and quantitative PCR.
o Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Microbial Identification, Contamination testing and Growth Promotion.
o Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
o Performance testing: Panther, Tigris, RT Polymerase, T7 Enzyme Activity, Chemiluminescence, Binding Capacity Assay, Magnetic Particle Concentration..
o Environmental/Utility/facility Monitoring testing such as Sampling of and testing of manufacturing water by membrane filtration, viable and non-viable particulate testing of facilities and utilities, viable (surface) monitoring of manufacturing facilities
o Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and, microbiology or complendial test methods
o Assay trouble shooting experience in their expert area
o Pharmacoepeial (compendial) test methods for Raw Materials, color and appearance, identity by FTIR, heavy metals, residual solvents, chloride, sulphate, insoluble matter
Proficient in MS Word, MS Power-point and MS Excel software
Must be familiar with GMP's and Quality System Regulations (QS Regs)
Must have good time management, effectively prioritizing tasks for completion
Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.
Must meet the two (2) mission critical competencies listed below:
- 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.
Req ID: 275184