Senior Microbiologist - Sanford, United States - Integrated Resources, Inc ( IRI )

Description

Title: Microbiology Senior Scientist

Location: Sanford, NC

Duration: 6 Months

Shift: Wednesday – Saturday first shift (4 days x 10 hours)

Job Description:

• Responsible for analyzing drug products, drug substances and environmental monitoring microbiological contamination to support our quality programs.
• Environmental testing, bioburden testing, endotoxin testing, microbial identifications, and sterility testing.
• 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 handling laboratory investigations for events and Out of Specification results.
• Perform testing including 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:

• 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 bachelor's 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.

Nice-to-Have:

• 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.