Senior Microbiologist

Location:
Sandy, UT 84070

Core Hours will be between 8 am – 5 pm Monday – Friday

Onsite Role

• 21 CFR Part 210/211
• BS in Microbiology, Biology, or Biochemistry (or equivalent experience)
• Investigation writing
• Microbiological Risk Assessment
• Pharmaceutical/Drug Manufacturing
• Technical Review

• Microbiology professional reporting to Quality Assurance by performing and reviewing a broad range of analytical microbiological assessments of moderate complexity on raw materials and finished goods.
• Technical writing to support risk assessment and Quality evaluation.
• Supports these activities with the necessary preparation, quality assurance, calibration and documentation.
• Works independently or co-operatively on special projects as required.
• Understanding of microbiological compendial publications.

• Microbial trending, assessment and analysis of reported results from finished goods, intermediates, and raw materials.
• Evaluates and reviews microbial and particulate testing to support environmental monitoring program.
• Assist in the development, validation, and remediation of test methods.
• Preparation of various microbiological technical reports.
• As a microbiological SME, conducts documentation review, approval, and researches/evaluates emergent regulatory/compendial standards to ensure compliance.
• Create and execute protocols, risk assessments, reports and/or other technical documents to support laboratory and Quality goals.
• Assist with technical writing, review, and assessment tasks for project and CAPA completion.
• Communicate with leadership and Quality Control/Assurance on product or project status.
• Ensures tasks and projects are completed in a timely manner, with minimal supervision.
• Operates independently with a strategic and self starter mindset.
• Responsible for direct CAPA completion and summary write up in support of audit preparation.
• Authors or updates controlled documents utilizing site change control processes.
• Ensures testing and documentation are performed according to GMP and GDP practices.
• Trend analysis of acceptable and OOS results in support of reports, risk assessments and audit preparation.
• Participate in document reviews and assessment to support alignment with corporate policies.
• Comply with all local, state, federal, and Client safety regulations, policies, and procedures including RCRA Hazardous waste regulations.