Quality St. Specialist

Location: 

CA-Los Angeles, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  333010

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, pharmacies, and healthcare professionals with the tools, information and services they need to deliver expert medical care. Grifols’ three main divisions – Bioscience, Diagnostic & Hospital – develop, manufacture, and market innovative products and services available in more than 100 countries. At Grifols we are united around a strong sense of pride, operating under the highest standards for quality and safety.

 

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. We would love for you to consider growing your career with us.  If challenging and meaningful work excites you, make a difference and join us in this rewarding enterprise!

Job Summary:

 

The Quality Statistics Specialist provides technical assistance and expertise in statistical data analysis for Annual Product Quality Review (APQR), product and laboratory investigations, process validation, equipment/ facility/utility and computer qualification.  Assist Quality and Manufacturing management in implementation of compliance and efficiency projects.  Perform review and approval of deviation and product complaint investigations.  Preparation of compliance related reports.

 

Essential Job Duties:

 

  • Provide statistical consulting, study design, and analysis for investigations, process improvement and problem-solving efforts in manufacturing and supporting areas. Examples include: 
  • Designing of experiments to understand and improve processes.
  • Conducting multivariate analysis to understand relationships in process variables.
  • Data Mining of manufacturing or laboratory data.
  • Applying statistical process control methods, including multivariate methods.
  • Designing and analyzing variance component studies.
  • Performing stability analyses using ANCOVA.
  • Developing and implementing sampling strategies.
  • Designing and reviewing of protocols to validate or transfer analytical assays.
  • Proactively mentoring and developing statistical problem-solving skills with the technical support staff.
  • Helping drive the incorporation of statistical tools into manufacturing and associated analytical laboratories.
  • Developing and administering training courses on various statistical concepts and methodologies, including statistical process control, basic statistics and experimental design.
  • Provide QA input to manufacturing and supporting areas related to investigations and compliance related reports and systems.  Examples include: 
  • Reviewing and approving deviation and product complaint investigations.
  • Evaluating product impact and root cause analysis of deviations.
  • Preparing Quarterly Product Quality reports.
  • Supporting implementation of compliance and efficiency improvement projects 
  • Maintain current knowledge of regulatory and industry standards.
  • Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
  • Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
  • Strict adherence to procedures and practices according to FDA regulations.
  • Strong emphasis on documentation according to FDA regulations.
  • Adhere to departmental corporate safety policies.

 

Job Requirements:

 

  • Bachelor of Science degree in Statistics / Math or closely related discipline is required.  Master’s degree in Statistics / Math or closely related discipline is preferred.
  • Experience in quality statistics / statistical analysis in a pharmaceutical, GMP, or FDA regulated environment is preferred.
  • Requires an in depth understanding of statistics and statistical analysis.
  • Knowledge or background in Quality systems and theory is preferred.
  • Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
  • Ability to work independently with minimum supervision.
  • Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
  • Must be proactive, results oriented, and have strong attention to detail.
  • Self-starter with strong work ethic and the ability to exercise good judgment.
  • Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
  • Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
  • Excellent verbal and written communication skills in the English language.
  • Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
  • Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
  • Computing skills/ experience is desired, specifically JMP and/or SAS is highly preferred.

 

*This job description is accurate at the date of publication.  It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position.  Other duties may be assigned and qualifications required may change over time.

 

EEO Minorities/Females/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-Los Angeles:USVALLEY - Valley - Valley Blvd - LA, CA 

 

Learn more about Grifols

 


Nearest Major Market: Los Angeles