Manager, QC Microbiology & Biology

Employer
Grifols
Location
Los Angeles County, California, US
Salary
Competitive
Posted
Jul 21, 2021
Closes
Jul 24, 2021
Ref
2331962993
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
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.

POSITION SUMMARY

Responsible for overall operations of the QC Microbiology and Biology Lab, ensuring that all required tests are completed in a timely and GMP-complaint manner.

ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.
  • Develop and maintain a schedule for the Microbiological and biological testing of process intermediates and final product that meets product distribution requirements, as well as all the tasks performed in QC Microbial Identification Lab
  • Identify all resources, including staff, equipment and supplies, that are required to perform testing of process intermediates and final products as well as other tests in supporting Validation and QA investigation.
  • Maintain system for timely purchase of laboratory equipment and reagents; maintain QC Microbiology budget.
  • Review QC Microbiology and biology test records. Perform routine trending analysis and generate reports on environmental monitoring data and other microbiology/biology data as needed.
  • Identify the cause(s) behind out of specification (OOS) results and generate comprehensive OOS reports with suggestions for corrective action(s).
  • Generate new procedures or improve existing procedures, write or edit lab procedures and submit to change control.
  • Provide information for internal and external audits on the GMP status of QC Microbiology and Biology equipment, reagents, facilities, laboratory practices, personnel training and related documents; investigate and assist in the resolution of audit.
  • Notify QC senior management of any potential quality issues and provide recommendations for quality improvement.
  • Oversee and generate, when needed, validation protocols for instruments and methods used in QC Microbiology and Biology lab.
  • Provide guidance and support to supervisors in QC Microbiology and Biology labs. Conduct performance review.

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
  • Bachelor degree required. M.S. or Ph.D. in Microbiology or related Life Sciences field preferred.
  • 5 years experience in laboratory management with 2 years spent in a cGMP environment. Strong knowledge of microbial method validation and testing on Bioburden, Sterility, Microbial identification, endotoxin, safety, pyrogen and diphtheria.
  • Strong leadership, communication, interpersonal, organizational and decision making skills.
  • Translates vision into reality by deciphering corporate message and implementing strategy.
  • Interprets business strategy and develops objectives to align with and support the strategy.
  • Works on issues of a diverse scope where analysis of the situation requires the evaluation of a variety of factors.
  • Develops and administers schedules.
  • Guiders staff to achieve tactical and strategic business goals.
  • Develops value-added solutions that meet internal and/or external customer needs.
  • Manages the functional processes and staff for a department; may report to another Department Leader.
  • Strong tactical decision-maker with ability to handle unforeseen issues. Erroneous decisions or failure to achieve results will add to costs and may impart the short -term goals of the company.
  • Frequently interacts cross-functionally with peer managers. Interactions normally requires the ability to gain cooperation of others.
  • May develop and recommend with senior management financial goals/budgets for a single department. Recommends how resources should be allocated within the department in order to meet business goals.
  • Moderate spending authority includes purchase requisitions and expense reports.

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