Microbiologist in Sanford, NC

3 weeks ago

Sanford, United States Rangam Full time

Pay Scale: $53.00 - $68.00 per Hourly


Job Description:

What will the resource be working with, or, have exposure to?:

  • Biohazardous Agent work (such as menigiditis, staph aureus, Lenti Virus, streph pneumoniae)
  • Neisseria meningitidis serogroup A,C, Y,W
  • Neisseria meningitidis serogroup B
  • Staph aureus
  • Strep Pneumoniae


What is the minimum education experience required?:

  • Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.

Duties:

  • Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
  • Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented.
  • Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

  • As a Microbiology Senior Scientist, you will be a member of Client dedicated and highly effective quality assurance and control team.
  • You will be responsible for analyzing drug product, drug substance and environmental monitoring microbiological contamination to support our quality programs.
  • Your contribution to environmental testing, bioburden testing, endotoxin testing, microbial identifications, and sterility testing will help client provide safe drugs to patients.
  • Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards.

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
  • Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
  • Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
  • Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.
  • Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
  • Train junior colleagues and develop training plans and oversee training activities for groups.
  • Responsible for contributing to and/or handle laboratory investigations for events and Out of Specification results.
  • Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
  • Perform laboratory support functions and maintain work area in a neat and orderly manner.
  • Write Standard Operating Procedures, technical reports, project plans and other documents independently.


Qualifications:

Must-Have

  • Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
  • Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.
  • Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
  • Understanding of aseptic laboratory techniques and quality systems
  • Ability to establish relationships within business lines.
  • Excellent effective written and verbal communication and interpersonal skills


Nice-to-Have

  • 3-5 years of experience in Microbiology laboratory analysis
  • Experience dealing with Quality Operations and Quality Assurance
  • Experience in training other employees in microbial assays.
  • Experience in review of Microbiology analysis data


PHYSICAL/MENTAL REQUIREMENTS:

  • Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
  • Intellectual capability to perform complex mathematical problems and perform complex data analysis.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Work schedule is an alternate shift with priority covering weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.


Position Comments visible to Supplier:

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