Microbiologist in Sanford, NC - Rangam

Description

Pay Scale: $ $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:

• Health Care/Pharma Exp