Job Description
: 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 Scientist, you will be a member of ***'s 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 *** 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 years of experience in Microbiology laboratory analysis
• 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.
Work Location Assignment: On Premise
Shift: Monday - Friday first shift
Health Care/Pharma Exp
Panel Interview Virtual
Position Comments visible to Supplier: Health Care/Pharma Exp
